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Proform 9603605R2

by Keystone Industries

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

Ref 9603605R2

Proform 9603605R2 is a device classified as Class I (EU), Unclassified (US) made by Keystone Industries, registered in EUDAMED on 15 Apr 2026 (Basic UDI-DI ++H668VFM00158) and listed in FDA GUDID since 30 Nov 2022 (UDI-DI ++H6689603605R21), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++H668VFM00158 Basic UDI-DI ++H6689603605R21UDI-DIDate15 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number++H6689603605R21 UDI-DI Date30 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++H668VFM00158 registered 15 Apr 2026 Active
  • FDA GUDID UDI-DI ++H6689603605R21 listed 30 Nov 2022 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID ++H6689603605R21
  2. Registered EUDAMED ++H668VFM00158

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Dual Laminates EUDAMED
Proform GUDID
Generic name
Dental appliance fabrication material, thermoplastic
Device name
Vacuum Forming Materials
Model / Ref / Catalog
9603605R2
Primary DI / UDI-DI
++H6689603605R21 EUDAMED
H6689603605R21 GUDID
Basic UDI-DI
++H668VFM00158
FDA product code
MQC
EMDN code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN term
Dental appliance fabrication material, thermoplastic
Device class
Class I EUDAMED
U GUDID
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
++H6689603605R21
GUDID
H6689603605R21
Device classEUDAMED
Class I
GUDID
U

The registries describe this device under different primary UDI-DIs (EUDAMED lists ++H6689603605R21; FDA GUDID lists H6689603605R21), so their flags are not compared. Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), U in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental appliance fabrication material, thermoplastic

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

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)