Identity
- Trade Name
- Hu-Friedy EUDAMEDFDA UDI
- Generic Name
- Dental restoration carver, amalgam, reusable FDA UDI
- Device Name
- #3 Andrews DE Carver FDA UDI
- Model / Reference
- Dental Device EUDAMEDCVA3 EUDAMEDFDA UDI
- Description
- #3 Andrews DE Carver FDA UDI
Identifiers
- Catalog Number
- CVA3 FDA UDI
- Primary DI / UDI-DI
- 10889950007492 EUDAMEDFDA UDI
- Basic UDI-DI
- 0889950Place1RU EUDAMED
- FDA Product Code
- EKH FDA UDI
- EMDN Code
- L159017 DENTAL RESTORATION CARVERS, REUSABLE EUDAMED
- GMDN Term
- Dental restoration carver, amalgam, 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 | 0889950Place1RU | 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 206d9bd9-33c5-47f3-b2d5-d8e3593b701c 61 fields · synced Jul 10, 2026
- FDA UDI 9e307b8e-86a5-42bb-8071-798b89fdedab 35 fields · synced May 30, 2026