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Drs Light Claver
EUDAMEDFDA UDIClass I (EU MDR)
Ref Drs Light ClaverModel CL-DC20
Identity
- Trade Name
- Drs Light Claver EUDAMEDFDA UDI
- Generic Name
- Dental/surgical polymerization lamp FDA UDI
- Device Name
- Curing light EUDAMEDACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION FDA UDI
- Model / Reference
- CL-DC20 EUDAMEDFDA UDIDrs Light Claver EUDAMED
- Description
- ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800025400081 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000254DC20EY EUDAMED
- 510(k) Number
- K093751 FDA UDI
- FDA Product Code
- EBZ FDA UDI
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
- GMDN Term
- Dental/surgical polymerization lamp FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6070 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Drs Light Claver by Good Doctors Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000254DC20EY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Good Doctors Co., Ltd.
- EUDAMED SRN
- KR-MF-000035314
- Authorised Representative
- Good Doctors Germany GmbH DE-AR-000025472
Sources (2)
- EUDAMED d360d0f4-d5a6-42e2-b36a-78736fd412eb 61 fields · synced Aug 5, 2026
- FDA UDI b51d9360-d228-426d-958b-46c0238deb74 34 fields · synced May 30, 2026