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E-System Implant Surgical Kit, Standard
EUDAMEDClass IIa (EU MDR)
Ref 0748-DI0SK00036EModel E-System Implant Surgical Kit, Standard
Identity
- Trade Name
- E-System Implant Surgical Kit, Standard EUDAMED
- Device Name
- E-System Implant Surgical Kit, Standard EUDAMED
- Model / Reference
- E-System Implant Surgical Kit, Standard EUDAMED0748-DI0SK00036E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719874672270 EUDAMED
- Basic UDI-DI
- 471987675KT0005JX 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
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
E-System Implant Surgical Kit, Standard by INTAI Technology Corp. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
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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 | 471987675KT0005JX | 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 49d271f6-c818-4189-b484-c85af7f193d1 61 fields · synced Jun 18, 2026