Identity
- Device Name
- WATERPROOF CAST/BANDAGE PROTECTOR EUDAMED
- Model / Reference
- FS-2120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942272621207 EUDAMED
- Basic UDI-DI
- 69422726P4.01.01XD EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Category: Hand/finger splint, reusable
Discover the innovative WATERPROOF CAST/BANDAGE PROTECTOR, a highly effective medical device designed to provide superior comfort and protection for wounded limbs. Developed with cutting-edge technology, this waterproof cast/bandage protector is engineered to ensure optimal healing outcomes while minimizing discomfort for patients. With its robust design and advanced materials, it's the perfect solution for healthcare professionals seeking reliable and durable solutions for wound care.
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
- Plastalume — BROWNMED, INC. · 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
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69422726P4.01.01XD | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- FIRSTAR HEALTHCARE COMPANY LlMITED(GUANGZHOU)
- EUDAMED SRN
- CN-MF-000009645
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED d388cc33-8b21-4f06-8dfd-16dbfb5539cf 61 fields · synced Oct 7, 2026