Identity
- Trade Name
- Hu-Friedy EUDAMEDFDA UDI
- Generic Name
- Dental surgical probe, reusable FDA UDI
- Device Name
- NT11.5B/NTOW DE COLOR-CODED PROBE FDA UDI
- Model / Reference
- Dental Device EUDAMEDPCP4435 EUDAMEDFDA UDI
- Description
- NT11.5B/NTOW DE COLOR-CODED PROBE FDA UDI
Identifiers
- Catalog Number
- PCP4435 FDA UDI
- Primary DI / UDI-DI
- 10889950081478 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 |
Is this your device? Claim it to add documentation and request validation.
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 7ecb7ca2-d6a5-4225-8923-5f6ccf1198bb 61 fields · synced Jul 29, 2026
- FDA UDI 0a801faf-d75d-467c-b29b-2518c9fe17b1 35 fields · synced May 30, 2026