Identity
- Device Name
- Assisting Rail and Grab Bar EUDAMED
- Model / Reference
- A-0160I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04712867051601 EUDAMED
- Basic UDI-DI
- 471286705GB1H3 EUDAMED
- Direct Marketing DI
- 04712867051601 EUDAMED
- EMDN Code
- Y181809 ARMRESTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Assisting Rail and Grab Bar by Shih Kuo Enterprise 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 | 471286705GB1H3 | Class I | Active |
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Manufacturer
- Manufacturer
- Shih Kuo Enterprise Co., Ltd.
- EUDAMED SRN
- TW-MF-000012251
- Authorised Representative
- KOMAS Medical Technology GmbH DE-AR-000045617
Sources (1)
- EUDAMED c43a6dc8-6ed1-4656-b3ff-f0ea69079595 61 fields · synced Jun 19, 2026