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Any-Paste

by MEDICLUS Co., Ltd.

Ref GB2021OC005Model 505-1 Any-Paste

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880951834EN07K5 Basic UDI-DI 08809518341511UDI-DIDate21 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809518341511 UDI-DI Date1 Jun 2026ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
Endodontic temporary cement
Device Name
Dental temporary filling material
Model / Ref / Catalog
505-1 Any-Paste EUDAMED
GB2021OC005 EUDAMED
505-1 GUDID
EC2501001 GUDID
Primary DI / UDI-DI
08809518341511
Basic UDI-DI
880951834EN07K5
Direct Marketing DI
08809518341511
510(k) Number
FDA Product Code
KIF
EMDN Code
Q01010201 Root canal filling dental pastes
GMDN Term
Endodontic temporary cement
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3820
EU market of registration
Croatia
GUDID distribution status
In Commercial Distribution
Size
Weight — 2 Gram

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
505-1 Any-Paste
GB2021OC005
GUDID
505-1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
KR-MF-000022584
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from MEDICLUS Co., Ltd.

See all devices from MEDICLUS Co., Ltd. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Premarket Exempt: No
  • Serial Number: No