Identity
- Trade Name
- Hu-Friedy EUDAMEDFDA UDI
- Generic Name
- Dental surgical probe, reusable FDA UDI
- Device Name
- Probe UNC #UNC15 CH Hdl Qulix, 1-15 FDA UDI
- Model / Reference
- Dental Device EUDAMEDPCPUNC15CH EUDAMEDFDA UDI
- Description
- Probe UNC #UNC15 CH Hdl Qulix, 1-15 FDA UDI
Identifiers
- Catalog Number
- PCPUNC15CH FDA UDI
- Primary DI / UDI-DI
- 10889950082062 EUDAMEDFDA UDI
- Basic UDI-DI
- 0889950Diagnostic1AZ EUDAMED
- FDA Product Code
- EIX FDA UDI
- EMDN Code
- L159003 DENTAL AND PERIODONTAL PROBES AND EXPLORERS, REUSABLE EUDAMED
- GMDN Term
- Dental surgical probe, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Hu-Friedy by Hu-Friedy Manufacturing Co., LLC — 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 | 0889950Diagnostic1AZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hu-Friedy Manufacturing Co., LLC
- EUDAMED SRN
- US-MF-000017104
- Authorised Representative
- Hu-Friedy Europe LLC & Co. KG DE-AR-000005530
Sources (2)
- EUDAMED b4cb8a9a-4220-4acb-b64a-eadcd3816cdd 61 fields · synced Jul 11, 2026
- FDA UDI 86f73e7b-721b-4ab1-9f9e-375bd06b4047 35 fields · synced May 30, 2026