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PRIMA Orthopedic Wool 3m x 15cm, 1 roll (1180-3x15)
EUDAMEDClass I (EU MDR)
Ref 1180-3x15
Identity
- Trade Name
- PRIMA Orthopedic Wool 3m x 15cm, 1 roll (1180-3x15) EUDAMED
- Device Name
- Absorbent cotton dressing EUDAMED
- Model / Reference
- 1180-3x15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454724537 EUDAMED
- Basic UDI-DI
- 69514547310UZ EUDAMED
- EMDN Code
- M0303010103 ELASTIC FIXING BANDAGES, NON-ADHESIVE, EXTENSIBLE IN TWO DIRECTIONS 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
PRIMA Orthopedic Wool 3m x 15cm, 1 roll (1180-3x15) by Gauke Healthcare 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 | 69514547310UZ | Class I | Active |
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Manufacturer
- Manufacturer
- GAUKE Healthcare Co., Ltd
- EUDAMED SRN
- CN-MF-000013784
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 4a60ea09-c1c9-4376-a8a8-f0579af26e7b 61 fields · synced Oct 8, 2026