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Pro-Form Soft EVA

by Keystone Industries 10 variants

Part of a family of 63 devices: see the family page

Ref 9597130PP

Pro-Form Soft EVA (9597130PP) is a Class I device made by Keystone Industries, registered in EUDAMED on 15 Apr 2026 (Basic UDI-DI ++H668VFM00158), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++H668VFM00158 Basic UDI-DI ++H6689597130PP1UDI-DIDate15 Apr 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Vacuum Forming Materials
Model / reference
9597130PP
Primary DI / UDI-DI
++H6689597130PP1
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

Similar devices in this category

Other devices filed under MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER.

Other devices from Keystone Industries

See all devices from Keystone Industries →

Properties

Other properties (14, all answered No)