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Maxtaping A+

by OPPO Medical Inc. 18 variants

Ref 8095-PK-S

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 Number08402706CL1114N Basic UDI-DI 00840270627497UDI-DIDate12 Sep 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00840270627497 UDI-DI Date1 Dec 2022ListedStatusListed 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  • Withdrawn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

Generic Name
Pressure bandage, non-latex, single-use
Device Name
Tapes
Model / Ref / Catalog
8095-PK-S, 8095
Primary DI / UDI-DI
00840270627497
Basic UDI-DI
08402706CL1114N
FDA Product Code
KOX
EMDN Code
M0599 Medical plasters - other
GMDN Term
Pressure bandage, non-latex, single-use
Device Class
Class I
Regulation Number
878.4730
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution
Size
Length — 14 Centimeter

Manufacturer details

EUDAMED SRN
US-MF-000005202
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from OPPO Medical Inc.

See all devices from OPPO Medical Inc. →

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