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Sterizone PU Polyurethane Waterproof Wound Dressing
EUDAMEDClass I (EU MDR)
Ref 4154-107-(9cm x 15cm)-ST PU-57Model AWD-PU
Identity
- Trade Name
- Sterizone PU Polyurethane Waterproof Wound Dressing EUDAMED
- Device Name
- Adhesive Wound Dressings (Polyurethane) EUDAMED
- Model / Reference
- AWD-PU EUDAMED4154-107-(9cm x 15cm)-ST PU-57 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904044234006 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 (1)
- EUDAMED d6b4b858-9478-4663-9d4b-2606c6a9cf59 61 fields · synced Jun 18, 2026