Identity
- Trade Name
- Instrument support arm EUDAMED
- Device Name
- Instrument support arm EUDAMED
- Model / Reference
- HJ-FZCB EUDAMEDmany EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979116351228 EUDAMED06979116351211 EUDAMED
- Basic UDI-DI
- 697717774HJ-FZCBXS EUDAMED
- Direct Marketing DI
- 06979116351228 EUDAMED06979116351211 EUDAMED
- EMDN Code
- L0318 INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Instrument support arm by Hangzhou HuaJan Medical Robotics 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 | 697717774HJ-FZCBXS | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou HuaJan Medical Robotics Co., Ltd.
- EUDAMED SRN
- CN-MF-000046088
- Authorised Representative
- Surpass Biomedical Europe B.V. NL-AR-000038619
Sources (2)
- EUDAMED a0e27194-e5af-426d-b921-59435283dbf4 61 fields · synced Jul 23, 2026
- EUDAMED b591f9af-ae75-446e-abe3-d5136c9eeadd 61 fields · synced May 19, 2026