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SP2000 Elegance
EUDAMEDClass I (EU MDR)
Ref SP2000 EleganceModel Smart P2000 Classic、Smart P2000 Plus、 Smart P2000 Advantage、Smart P2000 Elegance
Identity
- Trade Name
- SP2000 Elegance EUDAMED
- Device Name
- Smart P2000 Series Electric Surgical Table EUDAMED
- Model / Reference
- Smart P2000 Classic、Smart P2000 Plus、 Smart P2000 Advantage、Smart P2000 Elegance EUDAMEDSP2000 Elegance EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719879261189 EUDAMED
- Basic UDI-DI
- 471987926SmartP2000VE EUDAMED
- EMDN Code
- Z12011202 OPERATING TABLES 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
SP2000 Elegance by Mediland Enterprise Corporation — 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 | 471987926SmartP2000VE | Class I | Active |
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Manufacturer
- Manufacturer
- Mediland Enterprise Corporation
- EUDAMED SRN
- TW-MF-000012153
- Authorised Representative
- Luana Med. B.V. NL-AR-000002750
Sources (1)
- EUDAMED 117a6113-dda6-4d85-b1e3-b203a77a49b9 61 fields · synced Jun 19, 2026