← Back to catalogue
ARMBOARDS w/Stockinette
EUDAMEDClass I (EU MDR)
Ref SP 10434-25 Model 4 1/2" x 1 1/2"
Identity
- Trade Name
- ARMBOARDS w/Stockinette EUDAMED
- Device Name
- PLASTALUME® ARMBOARDS w/Stockinette EUDAMED
- Model / Reference
- 4 1/2" x 1 1/2" EUDAMEDSP 10434-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00821611043466 EUDAMED
- Basic UDI-DI
- 082161PABWS41212C 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
ARMBOARDS w/Stockinette by Brownmed, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hand/finger splint, reusable.
- Elastic Bandage — Anji Xinyuan Medical Supplies Co.,Ltd. · Class I
- Splint — Anping Guardian Medical Equipment Co., Ltd · Class I
- ORTHOSIS FRACTURE WRIST-HAND PLASTICAST — AliMed, LLC · Class I
- MedTextile — Medtex Swiss Ltd · Class I
- PERFORMANCE HEALTH — Asp Global, LLC · Class I
- McKie Thumb Splint Pediatric — McKie Splints, LLC · Class I
- McKie Thumb Splint Adult — McKie Splints, LLC · Class I
- Shaped vacuum leg splint TL125 — Mediseam Oy · Class I
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 | 082161PABWS41212C | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Brownmed, Inc.
- EUDAMED SRN
- US-MF-000008271
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 635932d0-dfad-4d1a-ac31-7d79f13c9511 61 fields · synced Jul 9, 2026