Manufactured in ISO 13485 cleanrooms under EU MDR 2017/745 standards, serving clinical centers across Jakarta, Tangerang, Depok, Bogor, and Bekasi.
In modern nephrology and surgical environments across Greater Jakarta (Jabodetabek), maintaining absolute sterility during hemodialysis access management, central venous catheterization (CVC), and vascular access surgical procedures is paramount. With the rapid expansion of chronic kidney disease (CKD) management programs under Indonesia’s BPJS Kesehatan health insurance system, public and private hospitals in Jakarta face an unprecedented demand for reliable, standardized, and infection-preventative medical disposables. As an established global OEM manufacturer and exporter of single-use surgical drapes, AAMI Level 2–4 gowns, customized procedure packs, and specialized dialysis kits, Surgeine Healthcare delivers internationally certified clinical consumables directly tailored to the regulatory, operational, and environmental requirements of Indonesian healthcare providers.
Clinical Insight for Jakarta Procurement Officers: Bloodstream Infections (BSIs) and Vascular Access-Site Infections represent major complications in maintenance hemodialysis. Standardizing pre-assembled, single-use sterile Dialysis On/Off Kits and catheter dressing packs drastically reduces catheter-related bloodstream infection (CRBSI) rates while saving up to 14 minutes of nurse setup time per patient session.
Hemodialysis care requires immaculate aseptic techniques at two critical junctures: initiation (On-Kit) and termination (Off-Kit) of the treatment session. Whether utilizing arteriovenous (AV) fistulas, synthetic grafts, or temporary/tunneled central venous hemodialysis catheters, clinical staff require pre-packaged, standardized sterile components to minimize airborne contaminants and contact transmission.
Our OEM customized dialysis kits integrate high-barrier medical textiles, validated chlorhexidine gluconate (CHG) skin prep solutions, absorbable dressing pads, and specialized fluid-repellent drapes designed according to AAMI PB70 and EN 13795 standards. By removing manual assembly in hospital wards, our kits eliminate cross-contamination risks inherent to multi-dose supply bottles and unsterilized tray preparation.
Multi-layer SMMS and SMS non-woven fabrics offering AAMI Level 2 to 4 protection against liquid strike-through and viral penetration under high fluid pressures.
Custom component layout, folding sequence, and color-coded towels configured precisely to match hospital-specific nephrology and OR protocols.
Fully validated 10⁻⁶ Sterility Assurance Level (SAL) with bio-burden monitoring and residual EO levels strictly below ISO 10993-7 thresholds.
Healthcare facilities across Jakarta operate under distinct environmental and high-throughput conditions. The humid tropical climate of Jakarta requires packaging materials with superior moisture-barrier properties and extended shelf-life stability to prevent premature seal degradation in non-air-conditioned storage spaces.
Major Public Referral Hospitals (e.g., RSUPN Dr. Cipto Mangunkusumo - RSCM, RSUP Persahabatan, RSUD Tarakan): High-volume hemodialysis centers in national referral centers care for complex patients with multi-organ comorbidities. These centers benefit from custom Dialysis Procedure Packs that include reinforced fenestrated drapes with high-absorbency zones, protecting both the patient and clinician during AV fistula cannulation and central venous catheter insertion.
Private Hospital Networks & Specialized Dialysis Clinics (e.g., Siloam Hospitals, RS Gading Pluit, Hermina Hospital Group): Private clinical chains prioritize operational efficiency, rapid patient turnover, and strict international accreditation standards (such as JCI and KARS). Utilizing pre-packaged sterile dressing change kits and AAMI Level 3 surgical gowns ensures predictable cost-per-procedure while reinforcing patient safety metrics.
Outpatient Hemodialysis Units & Satellite Clinics: For standalone hemodialysis centers spread throughout North, South, Central, East, and West Jakarta, managing bulk inventory can be challenging. Surgeine’s compact, ready-to-use Dialysis On/Off Packs drastically simplify inventory management, reducing storage footprint and stockout risks.
The Indonesian medical device market is undergoing significant modernization driven by health sector reforms (Undang-Undang Kesehatan No. 17 Tahun 2023) and the Ministry of Health’s (Kemenkes RI) digital health integration initiatives (SatuSehat). Key trends influencing procurement decisions in Jakarta include:
Selecting the appropriate barrier protection level is critical to balancing clinical safety with cost-efficiency. Over-specifying causes unnecessary expenditure and heat discomfort for medical personnel, while under-specifying increases strike-through and contamination risks.
| Classification Level | Fabric Construction | Hydrostatic Head (cm H₂O) | Impact Penetration (g) | Recommended Dialysis & OR Application |
|---|---|---|---|---|
| AAMI Level 1 | Spunbond Polypropylene (30 GSM) | > 20 cm | < 4.5 g | Basic patient cover, ward visitors, non-invasive dialysis examination |
| AAMI Level 2 | SMS Non-Woven (35-40 GSM) | > 50 cm | < 1.0 g | Standard Dialysis On/Off procedures, AV fistula dressing change, minor suturing |
| AAMI Level 3 | SMMS / Poly-Laminated (45-55 GSM) | > 90 cm | < 1.0 g | CVC catheter insertion, vascular access surgery, general surgery procedures |
| AAMI Level 4 | Breathable Film Laminate / Reinforced | > 140 cm (ASTM F1671 Viral Test) | 0.0 g (Passes viral penetration) | High-fluid vascular graft surgery, major trauma, prolonged arterial interventions |
Surgeine Healthcare stands as a premier manufacturer of infection control disposables and custom surgical procedure packs. Operating out of state-of-the-art cleanroom facilities with integrated vertical production capabilities, we empower medical equipment distributors and hospital networks serving Jakarta with tailored OEM, ODM, and private-label solutions.
Every lot undergoes rigorous internal testing for hydrostatic head pressure, tensile strength, particle linting, and bio-burden in accordance with EN 13795 and AAMI PB70 protocols prior to release.
We provide Indonesian importers with fully structured technical files, CE MDR 2017/745 certification, ISO 13485:2016 documentation, and customized packaging artwork for local Bahasa Indonesia compliance.
From component selection (gauze, drapes, tray sizes, forceps, tape) to folding order and sterile field orientation, we build dialysis and surgical packs strictly around your clinical workflow.
Quality and compliance travel with every container shipped to Tanjung Priok Port, Jakarta. Our manufacturing plant operates under ISO 13485:2016 and holds valid CE markings under EU MDR 2017/745, along with BIS and ZED Gold accreditations.
CE Certificate
ISO 13485
ZED Gold
Export House
BIS Certified
A standard Dialysis On/Off Kit can be fully customized based on facility preferences. Typically, the "On-Kit" includes non-woven fenestrated drapes with adhesive borders, CHG or povidone-iodine prep swabs, sterile gloves, gauze sponges, and AV fistula needles. The "Off-Kit" features pressure dressing pads, adhesive bandages, absorbent towels, biohazard disposal bags, and skin cleansing wipes. Component selection, tray size, and packaging configuration can be modified to meet specific clinical protocols.
We provide complete regulatory support dossiers required for obtaining AKL (Alat Kesehatan Luar Negeri) import permits from Kemenkes RI. This includes ISO 13485:2016 certificates, CE Mark declarations of conformity under EU MDR 2017/745, Free Sale Certificates (FSC), biocompatibility test reports (ISO 10993), sterilization validation data (ISO 11135 for EO), and customizable packaging layout compliant with Indonesian labeling regulations (Bahasa Indonesia instructions for use).
Production lead time typically ranges from 3 to 4 weeks depending on kit complexity and customization volume. Shipments are dispatched directly via ocean freight to Tanjung Priok Port (Jakarta) with a transit time of approximately 10 to 14 days. For urgent clinical hospital tenders or emergency restocking, expedited air freight delivery to Soekarno-Hatta International Airport (CGK) is available.
Yes. All Surgeine sterile consumables are packaged using high-integrity, medical-grade Tyvek or heavy-duty paper/film pouch combinations designed for tropical environments. Our peel pouches feature reinforced seal strengths that prevent humidity ingress, microbial penetration, and seal delamination, guaranteeing a validated 3-year to 5-year sterile shelf life even in challenging storage environments.
Yes. We specialize in comprehensive OEM and private-label manufacturing programs for medical device distributors, group purchasing organizations (GPOs), and hospital chains across Indonesia. We assist with custom inner pouch artwork, outer carton master designs, GTIN barcode generation, and precise pack configurations tailored to local tender requirements.
Looking to elevate clinical infection control standards, streamline hospital procurement, or expand your product portfolio in Greater Jakarta? Contact our technical export team today for customized kit specifications, sample requests, and competitive B2B pricing.