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Ourmed Hydrocolloid Dressing Standard

by Jiangsu NewValue Medical Products Co., Ltd.

Ref HDD-4N4ST-TTNL-10CNTModel Standard type

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06970206826855 UDI-DI Date18 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697020682HDSSHU Basic UDI-DI 06970206826855UDI-DIDate4 Jun 2026RegisteredStatusActive

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  • Withdrawn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
Ourmed EUDAMED
Ourmed Hydrocolloid Dressing GUDID
Generic Name
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Device Name
Hydrocolloid Dressing
Model / Reference
Standard type EUDAMED
HDD-4N4ST-TTNL-10CNT EUDAMED
Standard GUDID
Primary DI / UDI-DI
06970206826855
Basic UDI-DI
697020682HDSSHU
Unit of Use DI
26970206826859
FDA Product Code
NAD
EMDN Code
M04040301 Hydrocolloid dressings, non-combined
GMDN Term
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Device Class
Class IIb EUDAMED
Class I GUDID
Regulation Number
878.4020
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Standard type
HDD-4N4ST-TTNL-10CNT
GUDID
Standard
Device ClassEUDAMED
Class IIb
GUDID
Class I

Other devices from Jiangsu NewValue Medical Products Co., Ltd.

See all devices from Jiangsu NewValue Medical Products Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No