Identity
- Trade Name
- Hu-Friedy EUDAMEDFDA UDI
- Generic Name
- Dental elevator, tooth/root FDA UDI
- Device Name
- #46 Elevator FDA UDI
- Model / Reference
- Dental Intruments EUDAMEDE46 EUDAMEDFDA UDI
- Description
- #46 Elevator FDA UDI
Identifiers
- Catalog Number
- E46 FDA UDI
- Primary DI / UDI-DI
- 10889950008222 EUDAMEDFDA UDI
- Basic UDI-DI
- 0889950Remove1R2S EUDAMED
- FDA Product Code
- EMJ FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental elevator, tooth/root 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
Yes
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 | 0889950Remove1R2S | 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 254de188-ed22-4cec-a854-6b9861a54f06 61 fields · synced Jul 23, 2026
- FDA UDI a919c6bf-c6ef-4494-9747-f0a9783003ba 35 fields · synced May 29, 2026