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Flexacryl Soft Professional Package

by Lang Dental Manufacturing Company, Inc. 3 variants

Ref 1123P1

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, self-declared

Class I: no certifier involved

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
United StatesGUDID listing GUDID NumberD6501123P10 UDI-DI Date15 Apr 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++D6500978 Basic UDI-DI D6501123P10UDI-DIDate27 Dec 2021RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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
Flexacryl Soft Professional Package EUDAMED
Flexacryl Soft GUDID
Generic Name
Denture reliner, soft, professional
Model / Ref / Catalog
1123P1, PROFESSIONAL PACKAGE P1
Primary DI / UDI-DI
D6501123P10
Basic UDI-DI
++D6500978
FDA Product Code
EBI
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN Term
Denture reliner, soft, professional
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.3760
EU market of registration
Bulgaria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
1123P1
GUDID
PROFESSIONAL PACKAGE P1
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000003646
Authorised representative
MediMark Europe Sarl. FR-AR-000000182

From the manufacturer

Manufacturer's product page: Flexacryl™ Soft

Other devices from Lang Dental Manufacturing Company, Inc.

See all devices from Lang Dental Manufacturing Company, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: No
  • Implantable: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No