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Splints
EUDAMEDClass I (EU MDR)
Ref PS54Ref PS42Ref 26014Ref PS36Ref 26013Ref PS15Ref 26012Ref PS12
Identity
- Trade Name
- Splints EUDAMED
- Device Name
- Splints EUDAMED
- Model / Reference
- PS54 EUDAMEDPS42 EUDAMED26014 EUDAMEDPS36 EUDAMED26013 EUDAMEDPS15 EUDAMED26012 EUDAMEDPS12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975293690259 EUDAMED06975293690266 EUDAMED06975293690235 EUDAMED06975293690273 EUDAMED06975293690228 EUDAMED06975293690303 EUDAMED06975293690211 EUDAMED06975293690327 EUDAMED
- Basic UDI-DI
- 6975293692601189 EUDAMED
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Cotton wool roll, sterile
Splints by Medsource Factory, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 6975293692601189 | Class I | Active |
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Manufacturer
- Manufacturer
- Medsource Factory, Inc.
- EUDAMED SRN
- CN-MF-000047853
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (8)
- EUDAMED d2530c6b-b2d5-462d-a9b1-d226a7d98704 61 fields · synced Aug 3, 2026
- EUDAMED aaab06b2-20b3-4964-83d5-18956a58fbcd 61 fields · synced May 16, 2026
- EUDAMED d3849806-3eab-4044-adb8-d1d197257080 61 fields · synced May 17, 2026
- EUDAMED 8b0e39d9-a2a9-45a9-a499-1c2b0c42d421 61 fields · synced May 17, 2026
- EUDAMED 1261ed96-1eaf-43cb-9d94-9aa53d56569c 61 fields · synced May 17, 2026
- EUDAMED 49cd27c8-5acf-4a4c-ac66-110f269e6c68 61 fields · synced May 17, 2026
- EUDAMED 33a80e5c-18f5-484b-92f0-5c316e8e8f5c 61 fields · synced May 18, 2026
- EUDAMED 4c39ab60-23ac-4812-a193-365d63ac7ee2 61 fields · synced May 18, 2026