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BRACOO WB31 Wrist Fulcrum Wrap Ergo Splint & Light Support Black Free size
EUDAMEDFDA UDIClass I (EU MDR)
Ref 0Model WB30
Identity
- Trade Name
- BRACOO WB31 Wrist Fulcrum Wrap Ergo Splint & Light Support Black Free size EUDAMEDComfyHealth FDA UDI
- Generic Name
- Wrist/hand orthosis FDA UDI
- Device Name
- BRACOO WB30 Wrist Fulcrum Wrap Orth Ergo Cushion Splint EUDAMEDBRACOO WB31 Wrist Fulcrum Wrap Ergo Splint & Light Support / Grade 5 Black Free size FDA UDI
- Model / Reference
- WB30 EUDAMED0 EUDAMEDWB31 FDA UDI
- Description
- BRACOO WB31 Wrist Fulcrum Wrap Ergo Splint & Light Support / Grade 5 Black Free size FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719879643015 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987964WXXXYF EUDAMED
- Direct Marketing DI
- 04719879643015 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
BRACOO WB31 Wrist Fulcrum Wrap Ergo Splint & Light Support Black Free size by Comfy Health Group Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 8f4bee5b-04e0-4bcb-b70c-0ad7820b0dbd 61 fields · synced Jul 18, 2026
- FDA UDI 47372d46-0f35-4781-8e5c-7fa9c6bc54d2 34 fields · synced May 30, 2026