Identity
- Trade Name
- Integrated Surgical Table EUDAMED
- Device Name
- Integrated Surgical Table EUDAMED
- Model / Reference
- H18 EUDAMEDH16 EUDAMEDH6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978356271587 EUDAMED06978356271570 EUDAMED06978356271501 EUDAMED
- Basic UDI-DI
- 697835627ISTYB EUDAMED
- Direct Marketing DI
- 06978356271587 EUDAMED06978356271570 EUDAMED06978356271501 EUDAMED
- EMDN Code
- Z12011202 OPERATING TABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Integrated Surgical Table by SHANDONG HORO MEDICAL EQUIPMENT 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 | 697835627ISTYB | Class I | Active |
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Manufacturer
- Manufacturer
- SHANDONG HORO MEDICAL EQUIPMENT Co., Ltd.
- EUDAMED SRN
- CN-MF-000046718
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (3)
- EUDAMED 21d8476d-b44f-4a2f-a4fb-360fdf377ab3 61 fields · synced Oct 6, 2026
- EUDAMED f5b30105-dac3-4f07-8530-90dbd2895751 61 fields · synced May 18, 2026
- EUDAMED f3a6a98c-c6fd-4ec7-82f1-f972112d0d18 61 fields · synced May 18, 2026