Identity
- Trade Name
- Dental Examination Kit EUDAMED
- Device Name
- Dental Examination Kit EUDAMED
- Model / Reference
- DEK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964003663100 EUDAMED
- Basic UDI-DI
- 8964003662DentalExKitEQ EUDAMED
- EMDN Code
- L159016 DENTAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
Classification
- Device Class
- Class I 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
Dental Examination Kit by CENTRAL SURGICAL Co. (PVT) LTD. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 8964003662DentalExKitEQ | Class I | Active |
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Manufacturer
- Manufacturer
- CENTRAL SURGICAL Co. (PVT) LTD.
- EUDAMED SRN
- PK-MF-000035590
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 69854995-415a-4bbe-b0b4-b723197fd6ae 61 fields · synced Jul 24, 2026