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BRACOO TP33 Thumb Fulcrum Wrap Ergonomic Splint Black Free size
EUDAMEDFDA UDIClass I (EU MDR)
Ref 0Model TP32
Identity
- Trade Name
- BRACOO TP33 Thumb Fulcrum Wrap Ergonomic Splint Black Free size EUDAMEDComfyHealth FDA UDI
- Generic Name
- Wrist/hand orthosis FDA UDI
- Device Name
- TP32 Thumb Fulcrum wrap Ergonomic Stabilizer EUDAMEDBRACOO TP33 Thumb Fulcrum wrap Ergonomic Stabilizer Black FDA UDI
- Model / Reference
- TP32 EUDAMED0 EUDAMEDTP33 FDA UDI
- Description
- BRACOO TP33 Thumb Fulcrum wrap Ergonomic Stabilizer Black FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719879646498 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987964TXXXXS EUDAMED
- Direct Marketing DI
- 04719879646498 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
- 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 TP33 Thumb Fulcrum Wrap Ergonomic Splint Black Free size by Comfy Health Group Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 471987964TXXXXS | 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 6cff5cc2-3b38-4d70-8013-8ba2faec9b78 61 fields · synced Jul 12, 2026
- FDA UDI 3237bcc0-3e69-4afa-8c25-0e83374e184d 33 fields · synced May 30, 2026