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BRACOO BB30 Low Back Airy Wrap Orth Ergo Splint Black M-size
EUDAMEDFDA UDIClass I (EU MDR)
Ref 0Model BB30
Identity
- Trade Name
- BRACOO BB30 Low Back Airy Wrap Orth Ergo Splint Black M-size EUDAMEDComfyHealth FDA UDI
- Generic Name
- Static magnetic orthopaedic orthosis FDA UDI
- Device Name
- BRACOO BB30 Low Back Airy Wrap Orth Ergo Splint Black S-size EUDAMEDBRACOO BB30 Low Back Airy Wrap Orth Ergo Splint Black M-size FDA UDI
- Model / Reference
- BB30 EUDAMEDFDA UDI0 EUDAMED
- Description
- BRACOO BB30 Low Back Airy Wrap Orth Ergo Splint Black M-size FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719879641813 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987964BXXXTU EUDAMED
- Direct Marketing DI
- 04719879641813 EUDAMED
- FDA Product Code
- ISR FDA UDI
- EMDN Code
- M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER EUDAMED
- GMDN Term
- Static magnetic orthopaedic orthosis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3025 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 BB30 Low Back Airy Wrap Orth Ergo Splint Black M-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 | 471987964BXXXTU | 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 45dc60d2-735a-436c-8573-8bf7f6ce31fc 61 fields · synced Jul 24, 2026
- FDA UDI b4937f87-f68a-4ad5-8f0c-e187cdb1169c 34 fields · synced May 30, 2026