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BRACOO ES10 Elbow Fulcrum Wrap Comfort fit Black
EUDAMEDFDA UDIClass I (EU MDR)
Ref 0Model EE92
Identity
- Trade Name
- BRACOO ES10 Elbow Fulcrum Wrap Comfort fit Black EUDAMEDComfyHealth FDA UDI
- Generic Name
- Wrist/hand orthosis FDA UDI
- Device Name
- BRACOO EE92 Elbow Fulcrum Sleeve Breathable & 4-way stretch GrayS-size Pair EUDAMEDBRACOO ES10 Elbow Fulcrum Wrap Comfort fit Black FDA UDI
- Model / Reference
- EE92 EUDAMED0 EUDAMEDES10 FDA UDI
- Description
- BRACOO ES10 Elbow Fulcrum Wrap Comfort fit Black FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719879643855 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987964EXXXUH EUDAMED
- Direct Marketing DI
- 04719879643855 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 ES10 Elbow Fulcrum Wrap Comfort fit Black 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 | 471987964EXXXUH | 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 b4db9737-5e93-4e69-b927-155aaaee8c90 61 fields · synced Jun 18, 2026
- FDA UDI 17d8f0a6-d0a1-4e91-9c17-b7d0f4604c44 33 fields · synced May 27, 2026