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RS Surgical Guide RS001533

by DeltaMed GmbH

Ref RS001533Model Light curing resins for generative manufacturing of dental drill guides

RS Surgical Guide RS001533 is a Class I device made by DeltaMed GmbH, registered in EUDAMED on 13 Mar 2026 (Basic UDI-DI ++EDELTD11BUDI010028FC) and listed in FDA GUDID since 11 Feb 2022 (UDI-DI 04260635980481), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++EDELTD11BUDI010028FC Basic UDI-DI 04260635980481UDI-DIDate13 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260635980481 UDI-DI Date11 Feb 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++EDELTD11BUDI010028FC registered 13 Mar 2026 Active
  • FDA GUDID UDI-DI 04260635980481 listed 11 Feb 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 04260635980481
  2. Registered EUDAMED ++EDELTD11BUDI010028FC

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  • Withdrawn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
RS Surgical Guide
Generic name
Dental appliance fabrication material, resin
Model / Ref / Catalog
RS001533, Light curing resins for generative manufacturing of dental drill guides
Primary DI / UDI-DI
04260635980481
Basic UDI-DI
++EDELTD11BUDI010028FC
FDA product code
NDP
EMDN code
Q010399 Surgical dental devices - other
GMDN term
Dental appliance fabrication material, resin
Device class
Class I
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental appliance fabrication material, resin

Other devices from DeltaMed GmbH

See all devices from DeltaMed GmbH →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)