Pro-Form EVA Plus
by Keystone Industries 5 variants
Part of a family of 63 devices: see the family page
Ref 7000191PP
Pro-Form EVA Plus (7000191PP) is a Class I device made by Keystone Industries, registered in EUDAMED on 15 Apr 2026 (Basic UDI-DI ++H668VFM00158), active as of 23 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 | Number++H668VFM00158 ++H6687000191PP1 | Date15 Apr 2026 | StatusActive |
Official records
- EUDAMED public site ++H668VFM00158
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- Withdrawn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
- Vacuum Forming Materials
- Model / reference
- 7000191PP
- Primary DI / UDI-DI
- ++H6687000191PP1
- Basic UDI-DI
- ++H668VFM00158
- EMDN code
- Q010699 Materials for the preparation of custom-made dental devices - other
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000020203
- Authorised representative
- MDSS GmbH DE-AR-000005430
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