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Crutch
EUDAMEDClass I (EU MDR)
Ref BME1014Model Elbow crutch series: BME3000,BME3001,BME3002,BME3003,BME3003L,BME3004,BME3004L，BME3005，BME3006，BME3007，BME3008，BME3009，BME3010 Medical crutches series: BME11001,BME2000,BME2001,BME2002, etc
Identity
- Device Name
- Crutch EUDAMED
- Model / Reference
- Elbow crutch series: BME3000,BME3001,BME3002,BME3003,BME3003L,BME3004,BME3004L，BME3005，BME3006，BME3007，BME3008，BME3009，BME3010 Medical crutches series: BME11001,BME2000,BME2001,BME2002, etc EUDAMEDBME1014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971667720348 EUDAMED
- Basic UDI-DI
- 697512645CrutchJG EUDAMED
- EMDN Code
- Y12030603 CRUTCHES WITH UNDER-AXLE SUPPORT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria 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
Crutch by Shanghai Brother Medical Products Manufacturer 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 | 697512645CrutchJG | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000017485
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e5175544-fc86-44de-903f-8ed2a1cdda7e 61 fields · synced Jun 18, 2026