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Pressure Bandage
EUDAMEDClass I (EU MDR)
Ref 42.19.30002 42.19.30000 42.17.30001 42.17.30003 42.17.30004
Identity
- Device Name
- Pressure Bandage EUDAMED
- Model / Reference
- 42.19.30002 42.19.30000 42.17.30001 42.17.30003 42.17.30004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938820544944 EUDAMED
- Basic UDI-DI
- B-06938820544944 EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hand/finger splint, reusable
Pressure Bandage by SCW Medicath Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hand/finger splint, reusable.
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- McKie Thumb Splint Pediatric — McKie Splints, LLC · Class I
- Plastalume — BROWNMED, INC. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06938820544944 | Class I | Active |
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Manufacturer
- Manufacturer
- SCW Medicath Ltd.
- EUDAMED SRN
- CN-MF-000019140
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 6e12ab93-1ea2-4948-b22f-a175a4748139 61 fields · synced Jul 10, 2026