Identity
- Trade Name
- P-F Handle EUDAMEDNA FDA UDI
- Generic Name
- Manual non-rotary dental instrument handle FDA UDI
- Device Name
- GP Remover EUDAMEDThis device is a handle for attaching the working end of dental medical devices manufactured by YDM. FDA UDI
- Model / Reference
- GP Remover EUDAMED10205 EUDAMEDFDA UDI
- Description
- This device is a handle for attaching the working end of dental medical devices manufactured by YDM. FDA UDI
Identifiers
- Catalog Number
- 10205 FDA UDI
- Primary DI / UDI-DI
- 04963931102051 EUDAMEDFDA UDI
- Basic UDI-DI
- 4963931YDM00006WQ EUDAMED
- FDA Product Code
- EJB FDA UDI
- EMDN Code
- L159003 DENTAL AND PERIODONTAL PROBES AND EXPLORERS, REUSABLE EUDAMED
- GMDN Term
- Manual non-rotary dental instrument handle FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Austria 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
P-F Handle by Ydm Corporation — 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 | 4963931YDM00006WQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ydm Corporation
- EUDAMED SRN
- JP-MF-000011653
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED a65c712f-19ce-4ed8-9e47-d3ec31cbfe9a 61 fields · synced Jun 19, 2026
- FDA UDI 00587b09-fba1-4a94-9db6-f30a9175f51c 35 fields · synced May 30, 2026