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Medical gauze bandage non-sterile
EUDAMEDClass I (EU MDR)
Ref 001Model Medical gauze bandage non-sterile
Identity
- Device Name
- Medical gauze bandage non-sterile EUDAMED
- Model / Reference
- Medical gauze bandage non-sterile EUDAMED001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04780019143252 EUDAMED
- Basic UDI-DI
- 478001914TDoc-00372 EUDAMED
- EMDN Code
- M020107 COTTON GAUZES IN ROLLS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
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
Medical gauze bandage non-sterile by "ELASTIKUM" Limited Liability Company — 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 | 478001914TDoc-00372 | Class I | Active |
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Manufacturer
- Manufacturer
- "ELASTIKUM" Limited Liability Company
- EUDAMED SRN
- UZ-MF-000036753
- Authorised Representative
- AFINA, spol.s r.o. CZ-AR-000000584
Sources (1)
- EUDAMED 3c5db8cf-f645-4821-9cd6-2deb6c503f9a 61 fields · synced Jun 19, 2026