Identity
- Trade Name
- Sterile Wound Dressing EUDAMED
- Device Name
- Sterile Wound Dressing EUDAMED
- Model / Reference
- C053\ C054\ C055\ C056 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925923785152 EUDAMED
- Basic UDI-DI
- 69259237C053N2 EUDAMED
- EMDN Code
- M04010101 NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Sterile Wound Dressing by Hynaut Health Technology Co., 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 | 69259237C053N2 | Class I | Active |
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Manufacturer
- Manufacturer
- Hynaut Health Technology Co., LTD
- EUDAMED SRN
- CN-MF-000026762
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED f230e5db-3811-4221-bec4-5af7089ad4d9 61 fields · synced Aug 1, 2026