Identity
- Trade Name
- Ortlife EUDAMED
- Device Name
- Electric wheelchair EUDAMEDElectric scooter EUDAMED
- Model / Reference
- D60 EUDAMEDDC09L EUDAMEDFNS01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973175531195 EUDAMED06973175530921 EUDAMED06973175531157 EUDAMED
- Basic UDI-DI
- 697317553JBHD6008UA EUDAMED697317553JBHDC09L08TZ EUDAMED697317553JBHFNS01087A EUDAMED
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMEDY122124 ELECTRIC SCOOTERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Ortlife by Anhui Jbh Medical Apparatus 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 | 697317553JBHD6008UA | Class I | Active |
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Manufacturer
- Manufacturer
- Anhui JBH Medical Apparatus Co., Ltd
- EUDAMED SRN
- CN-MF-000008809
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED c672681b-9b4c-4e12-8a4b-055dfa670ffe 61 fields · synced Jul 17, 2026
- EUDAMED 2068c175-f6fc-4a26-9bac-1c40e60afbc4 61 fields · synced May 18, 2026
- EUDAMED b2b21cd5-087c-47e4-ba26-6a9222d37b4c 61 fields · synced May 18, 2026