Identity
- Trade Name
- 194.13SI modeling instr. bliss n2 EUDAMEDPRODONT-HOLLIGER FDA UDI
- Generic Name
- Dental restoration carver, amalgam, reusable FDA UDI
- Device Name
- Amalgam instruments EUDAMEDmodeling instr. bliss n2 FDA UDI
- Model / Reference
- 194.13SI EUDAMEDFDA UDI
- Description
- modeling instr. bliss n2 FDA UDI
Identifiers
- Catalog Number
- 194.13SI FDA UDI
- Primary DI / UDI-DI
- 03665224018087 EUDAMEDFDA UDI
- Basic UDI-DI
- 3665224AMALGAMINSTR3J EUDAMED
- Direct Marketing DI
- 03665224018087 EUDAMED
- FDA Product Code
- EIY FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER 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
- France 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
194.13SI modeling instr. bliss n2 by Prodont-Holliger — 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 | 3665224AMALGAMINSTR3J | 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
- Prodont-Holliger
- EUDAMED SRN
- FR-MF-000000956
Sources (2)
- EUDAMED b0ca7d9d-9b1f-4d83-984e-881659fabd2f 61 fields · synced Jun 18, 2026
- FDA UDI 1be91509-6caa-4390-ade3-b217da137e01 34 fields · synced May 30, 2026