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Prosthetic Surgical Kit
EUDAMEDClass IIa (EU MDR)
Ref 0748-001-DI0SK00074Model Prosthetic Surgical Kit
Identity
- Trade Name
- Prosthetic Surgical Kit EUDAMED
- Device Name
- Prosthetic Surgical Kit EUDAMED
- Model / Reference
- Prosthetic Surgical Kit EUDAMED0748-001-DI0SK00074 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719876733122 EUDAMED
- Basic UDI-DI
- 471987675KT0006JZ EUDAMED
- EMDN Code
- L159016 DENTAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Prosthetic Surgical Kit by INTAI Technology Corp. — Class IIa — 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 | 471987675KT0006JZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- INTAI Technology Corp.
- EUDAMED SRN
- TW-MF-000001158
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 13296e81-0411-4607-b753-162d8ba6d0ec 61 fields · synced Jun 19, 2026