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Dr's Finder
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref GDBR-DF-AL-DF10Model AL-DF10510(k) K151274
Identity
- Trade Name
- Dr's Finder EUDAMEDFDA UDI
- Generic Name
- Endodontic apex locator FDA UDI
- Device Name
- Apex Locator EUDAMEDLOCATOR, ROOT APEX FDA UDI
- Model / Reference
- AL-DF10 EUDAMEDFDA UDIGDBR-DF-AL-DF10 EUDAMED
- Description
- LOCATOR, ROOT APEX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800025400111 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000254DF10FC EUDAMED
- 510(k) Number
- K151274 FDA UDI
- FDA Product Code
- LQY FDA UDI
- EMDN Code
- Z12119009 APEX LOCATORS EUDAMED
- GMDN Term
- Endodontic apex locator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU 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 Finder by Good Doctors Co., Ltd. — Class IIa — 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 | K151274 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 88000254DF10FC | Class IIa | 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 (3)
- EUDAMED 7ef569b2-968d-4fb1-9ef7-9d62201c2bb7 85 fields · synced Jun 18, 2026
- FDA UDI 646484c6-7851-43ed-a348-7debbe233b09 34 fields · synced May 30, 2026
- FDA 510(k) K151274 1 fields · synced May 18, 2026