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Medical Tape

by Shanghai Ruiquan Medical Equipment Co., Ltd

Ref DFM01045YModel DFM01045Y,DTE16055Y,DSP01025Y,DNF08045Y

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
European UnionCE/MDR EUDAMED Number697558458MT001R4 Basic UDI-DI 06975584580009UDI-DIDate7 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06975584580009 UDI-DI Date22 May 2023ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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
Ruiquan
Generic Name
Exudate-absorbent dressing, non-gel, non-antimicrobial
Device Name
Medical Tape
Model / Reference
DFM01045Y EUDAMED
DTE16055Y EUDAMED
DSP01025Y EUDAMED
DNF08045Y EUDAMED
24 GUDID
Primary DI / UDI-DI
06975584580009
Basic UDI-DI
697558458MT001R4
FDA Product Code
NAC
EMDN Code
H900299 Tapes, medical/surgical - other
GMDN Term
Exudate-absorbent dressing, non-gel, non-antimicrobial
Device Class
Class I
Regulation Number
878.4018
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
DFM01045Y,DTE16055Y,DSP01025Y,DNF08045Y
DFM01045Y
GUDID
24

Manufacturer details

EUDAMED SRN
CN-MF-000010524
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No