BRACOO FP31 Ankle Fulcrum Pro WrapErgo Splint & Stabilizer Black L/XL
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- BRACOO FP31 Ankle Fulcrum Pro WrapErgo Splint & Stabilizer Black L/XL EUDAMEDComfyHealth FDA UDI
- Generic Name
- Multiple-joint lower limb orthosis FDA UDI
- Device Name
- BRACOO FP30 Ankle Fulcrum wrap Black L/XL EUDAMEDBRACOO FP31 Ankle Fulcrum Pro WrapErgo Splint & Stabilizer Black L/XL FDA UDI
- Model / Reference
- FP30 EUDAMED0 EUDAMEDFP31 FDA UDI
- Description
- BRACOO FP31 Ankle Fulcrum Pro WrapErgo Splint & Stabilizer Black L/XL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719879642889 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987964FXXXUQ EUDAMED
- Direct Marketing DI
- 04719879642889 EUDAMED
- FDA Product Code
- IQI FDA UDI
- EMDN Code
- M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER EUDAMED
- GMDN Term
- Multiple-joint lower limb orthosis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
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 FP31 Ankle Fulcrum Pro WrapErgo Splint & Stabilizer Black L/XL by Comfy Health Group Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 471987964FXXXUQ | 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 0585df02-f915-4af0-83f8-207bab78e44b 61 fields · synced Jun 18, 2026
- FDA UDI 00769370-f803-442b-b649-45b591438eff 33 fields · synced May 30, 2026