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Sterizone PU Polyurethane Waterproof Wound Dressing
EUDAMEDClass I (EU MDR)
Ref 4154-002-(5cm X 7cm)-ST PU-52Model AWD-PURef 4154-006-(9cm x 10cm)-ST PU-56 Ref 4154-011-(9cm X 25cm)-ST PU-61Ref 4154-013-(9cm X35cm)-ST PU-63Ref 4154-108-(15cm x 15cm)-ST PU-58
Identity
- Trade Name
- Sterizone PU Polyurethane Waterproof Wound Dressing EUDAMED
- Device Name
- Adhesive Wound Dressings (Polyurethane) EUDAMED
- Model / Reference
- AWD-PU EUDAMED4154-002-(5cm X 7cm)-ST PU-52 EUDAMED4154-006-(9cm x 10cm)-ST PU-56 EUDAMED4154-011-(9cm X 25cm)-ST PU-61 EUDAMED4154-013-(9cm X35cm)-ST PU-63 EUDAMED4154-108-(15cm x 15cm)-ST PU-58 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904044204542 EUDAMED08904044233993 EUDAMED08904044204559 EUDAMED08904044234020 EUDAMED08904044234013 EUDAMED
- Basic UDI-DI
- 89040442PUADSQ EUDAMED
- EMDN Code
- M04010102 POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterizone PU Polyurethane Waterproof Wound Dressing by Dynamic Techno Medicals Pvt Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 89040442PUADSQ | Class I | Active |
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Manufacturer
- Manufacturer
- Dynamic Techno Medicals Pvt Ltd
- EUDAMED SRN
- IN-MF-000017845
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (5)
- EUDAMED 6246c15f-4977-4e63-8d6f-19736a1b5a85 61 fields · synced Aug 3, 2026
- EUDAMED 65b34c42-9290-4dd0-89ff-221555416385 61 fields · synced May 17, 2026
- EUDAMED 9600be62-ba43-475f-b6de-f0827fac817d 61 fields · synced May 17, 2026
- EUDAMED 587faacf-2431-4bea-8be9-16dedab652ca 61 fields · synced May 18, 2026
- EUDAMED c911c9c9-f970-42c9-9612-8e7b0386fb56 61 fields · synced May 19, 2026