Identity
- Trade Name
- ComfyHealth FDA UDI
- Generic Name
- Static magnetic orthopaedic orthosis FDA UDI
- Device Name
- BRACOO BS80 Neck Fulcrum Wrap Breathable Black FDA UDI
- Model / Reference
- BS80 FDA UDI
- Description
- BRACOO BS80 Neck Fulcrum Wrap Breathable Black FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719879641929 FDA UDI
- FDA Product Code
- ISR FDA UDI
- GMDN Term
- Static magnetic orthopaedic orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3025 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
ComfyHealth by Comfy Health Group Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Comfy Health Group Co., Ltd.
Sources (1)
- FDA UDI 07f43b83-853c-412e-b28e-27950feaca2b 34 fields · synced Jun 1, 2026