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Dr's Light PRIME
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref Dr's Light PRIME / Dr's Light CHOICEModel CL-DP40510(k) K173157Ref Dr's LightModel CL-DL10
Identity
- Trade Name
- Dr's Light PRIME EUDAMEDFDA UDIDr's Light EUDAMEDFDA UDI
- Generic Name
- Dental/surgical polymerization lamp FDA UDI
- Device Name
- Curing light EUDAMEDACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION FDA UDI
- Model / Reference
- CL-DP40 EUDAMEDFDA UDIDr's Light PRIME / Dr's Light CHOICE EUDAMEDCL-DL10 EUDAMEDFDA UDIDr's Light EUDAMED
- Description
- ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800025400456 EUDAMEDFDA UDI08800025400074 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000254DP40H7 EUDAMED88000254DL10GA EUDAMED
- 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
Dr's Light PRIME by Good Doctors Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173157 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 88000254DP40H7 | Class I | Active |
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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 (5)
- EUDAMED 1733fa79-cb85-430c-a3cd-634b708232f1 85 fields · synced Jul 10, 2026
- FDA UDI b8867a5a-52e7-44a2-9786-55ff6f5bb951 34 fields · synced May 30, 2026
- FDA UDI 352827f7-8bc0-47b8-aec1-9d9083819ea9 34 fields · synced May 30, 2026
- EUDAMED 93574f30-a258-4d3e-ae8b-dcbf58b665b2 61 fields · synced Jul 10, 2026
- FDA 510(k) K173157 1 fields · synced May 18, 2026