Identity
- Trade Name
- FINGER SPLINTS-COTS EUDAMED
- Device Name
- PLASTALUME® FINGER SPLINTS-COTS EUDAMED
- Model / Reference
- Small Blue Foam EUDAMED10901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00821611091122 EUDAMED
- Basic UDI-DI
- 082161PFSCSMBF109CV EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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: Hand/finger splint, reusable
Finger Splints-Cots by Brownmed, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hand/finger splint, reusable.
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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 | 082161PFSCSMBF109CV | Class I | Active |
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Manufacturer
- Manufacturer
- Brownmed, Inc.
- EUDAMED SRN
- US-MF-000008271
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 1aceefb5-bb1b-4957-b0f1-15a767e75488 61 fields · synced Jul 28, 2026