Identity
- Trade Name
- Back brace with rotary machine EUDAMED
- Device Name
- Back brace with rotary machine EUDAMED
- Model / Reference
- FG-B020 (L) EUDAMED22 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976009954078 EUDAMED
- Basic UDI-DI
- 6976009954078DL EUDAMED
- Direct Marketing DI
- 06976009954078 EUDAMED
- EMDN Code
- V0880 MEDICAL SUPPORT EQUIPMENT - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Back brace with rotary machine by Xiamen LongStar Medical Equipment Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6976009954078DL | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen LongStar Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000034315
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED 664c1b85-c4b3-4339-92b2-e2aa1f96d15f 61 fields · synced Oct 10, 2026