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Integral dental unit
EUDAMEDClass IIa (EU MDR)
Ref K6PModel K2, K3, K4, K5, K6, K6P, K7, K7P, K8, K8P, K9
Identity
- Trade Name
- Integral dental unit EUDAMED
- Device Name
- Integral Dental Unit EUDAMED
- Model / Reference
- K2, K3, K4, K5, K6, K6P, K7, K7P, K8, K8P, K9 EUDAMEDK6P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975648840063 EUDAMED
- Basic UDI-DI
- 697564884KLXXX39 EUDAMED
- Direct Marketing DI
- 06975648840063 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
Category: Dental delivery system
Integral dental unit by Guangdong Kui Luk Medical Technology Co., Ltd. — Class IIa — 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 | 697564884KLXXX39 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangdong Kui Luk Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000030094
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 5afab339-ea2a-45e0-bf87-5ee4a79b1cb0 61 fields · synced Jun 19, 2026