Identity
- Device Name
- Handrails EUDAMED
- Model / Reference
- A-0131E3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04712867056323 EUDAMED
- Basic UDI-DI
- 471286705GB6HD EUDAMED
- Direct Marketing DI
- 04712867056323 EUDAMED
- EMDN Code
- Y181803 HANDRAILS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Handrails 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 | 471286705GB6HD | 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 088b3927-d95f-42d1-9a22-2c97e99415c2 61 fields · synced Jun 18, 2026