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Disposable Distal Tip Protector

by Yangzhou Fartley Medical Instrument Technology Co., Ltd.

Ref FTL-DTP-M-L

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 Number697090085102789 Basic UDI-DI 06936603209547UDI-DIDate1 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06936603209547 UDI-DI Date2 Feb 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  • Withdrawn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

Trade Name
Disposable Distal Tip Protector EUDAMED
Disposable Distal Tip Protectors GUDID
Generic Name
Endoscope transport/sterilization protective cover, single-use
Model / Reference
FTL-DTP-M-L
Primary DI / UDI-DI
06936603209547 EUDAMED
06936603225745 GUDID
Basic UDI-DI
697090085102789
Direct Marketing DI
06936603209547
FDA Product Code
MNL
EMDN Code
G0399 Digestive endoscopy devices - other
GMDN Term
Endoscope transport/sterilization protective cover, single-use
Device Class
Class I
Regulation Number
876.1500
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06936603209547
GUDID
06936603225745

Manufacturer details

EUDAMED SRN
CN-MF-000009371
Authorised representative
Prolinx GmbH DE-AR-000005129

Other devices from Yangzhou Fartley Medical Instrument Technology Co., Ltd

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Properties

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

Other properties (18)

  • 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