Hydent, French
Ref 05101
Hydent, French (05101) is a medical device (EU MDR Class I; EMDN category spray and liquid dental contact indicators) made by Pascal Company, Inc., registered in EUDAMED on 22 Mar 2024 (Basic UDI-DI 03108661001FP), active as of 25 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number03108661001FP 00310866002682 | Date22 Mar 2024 | StatusActive |
Official records
- EUDAMED public site 03108661001FP
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Hydent Denture Indicator Aerosol Paste
- Model / reference
- 05101
- Primary DI / UDI-DI
- 00310866002682
- Basic UDI-DI
- 03108661001FP
- EMDN code
- Q01020202 Spray and liquid dental contact indicators
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- US-MF-000032036
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
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