BRACOO WS11 Wrist Fulcrum Wrap Easyfit w/Splint
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- BRACOO WS11 Wrist Fulcrum Wrap Easyfit w/Splint EUDAMEDComfyHealth FDA UDI
- Generic Name
- Wrist/hand orthosis FDA UDI
- Device Name
- BRACOO WB30 Wrist Fulcrum Wrap Orth Ergo Cushion Splint EUDAMEDBRACOO WS11 Wrist Fulcrum Wrap Easyfit w/Splint FDA UDI
- Model / Reference
- WB30 EUDAMED0 EUDAMEDWS11 FDA UDI
- Description
- BRACOO WS11 Wrist Fulcrum Wrap Easyfit w/Splint FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719879640281 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987964WXXXYF EUDAMED
- Direct Marketing DI
- 04719879640281 EUDAMED
- FDA Product Code
- MRI FDA UDI
- EMDN Code
- M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER EUDAMED
- GMDN Term
- Wrist/hand orthosis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3490 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
Yes
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
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Compression/pressure sock/stocking, reusable
BRACOO WS11 Wrist Fulcrum Wrap Easyfit w/Splint by Comfy Health Group Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Compression/pressure sock/stocking, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471987964WXXXYF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Comfy Health Group Co., Ltd.
- EUDAMED SRN
- TW-MF-000047382
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 3e4bb90e-4ae4-4aac-90f9-86995e42545b 61 fields · synced Jul 13, 2026
- FDA UDI ebb5bfe6-51fc-4fef-b692-18fa5110c8e5 34 fields · synced May 30, 2026