Skip to content

Ceramir Pediatric Crown 71/O Size M

by edelweiss dentistry products gmbh

Ref 805141

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number912004632PaedCrownNY Basic UDI-DI 09120046326115UDI-DIDate21 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09120046326115 UDI-DI Date6 Mar 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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

Generic Name
Custom-made dental crown, polymer
Model / Reference
805141
Primary DI / UDI-DI
09120046326115
Basic UDI-DI
912004632PaedCrownNY
FDA Product Code
ELZ
EMDN Code
Q01020502 Pre-formed dental crowns
GMDN Term
Custom-made dental crown, polymer
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.3330
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I
ImplantableEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
AT-MF-000005413

Other devices from Edelweiss Dentistry Products GmbH

See all devices from Edelweiss Dentistry Products GmbH →

Properties

  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No