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Integral dental unit
EUDAMEDClass IIa (EU MDR)
Ref K7PModel K2, K3, K4, K5, K6, K6P, K7, K7P, K8, K8P, K9Ref K7Ref K5Ref K9Ref K2Ref K3Ref K8
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 EUDAMEDK7P EUDAMEDK7 EUDAMEDK5 EUDAMEDK9 EUDAMEDK2 EUDAMEDK3 EUDAMEDK8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975648840087 EUDAMED06975648840070 EUDAMED06975648840049 EUDAMED06975648840117 EUDAMED06975648840018 EUDAMED06975648840025 EUDAMED06975648840094 EUDAMED
- Basic UDI-DI
- 697564884KLXXX39 EUDAMED
- Direct Marketing DI
- 06975648840087 EUDAMED06975648840070 EUDAMED06975648840049 EUDAMED06975648840117 EUDAMED06975648840018 EUDAMED06975648840025 EUDAMED06975648840094 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 (7)
- EUDAMED 37726d1b-d4d0-4ced-89b9-059b2c821919 61 fields · synced Jul 27, 2026
- EUDAMED 79942ea4-186a-48c0-9100-71e5153ad428 61 fields · synced May 17, 2026
- EUDAMED 7319886d-e194-41ea-be4d-e8f7e120c1eb 61 fields · synced May 17, 2026
- EUDAMED 6de8ca6c-20fc-4bb6-b8f6-4feca7ae84bf 61 fields · synced May 17, 2026
- EUDAMED c62cf0c6-bea5-497b-aa47-fcccedcfb9c8 61 fields · synced May 17, 2026
- EUDAMED 44f9378f-6d7b-4e10-985c-eb382dab6ae0 61 fields · synced May 18, 2026
- EUDAMED bc3f98fa-9d01-4c78-9ce4-4437de35127a 61 fields · synced May 18, 2026