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Solventum™ V.A.C.® Granufoam™ M8275053/5 M8275053/10

by Kci USA, Inc. 2 variants

Ref M8275053/10 M8275053/5

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
European UnionCE/MDR EUDAMED Number084955408401010000000025X Basic UDI-DI 00197998300912UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00197998300912 UDI-DI Date22 Jul 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.

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  • Withdrawn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
Solventum™ V.A.C.® Granufoam™
Generic Name
Negative-pressure wound therapy system foam dressing, non-antimicrobial
Device Name
Solventum MDR V.A.C. Granufoam Dressing Kits
Model / Ref / Catalog
M8275053/10 M8275053/5 EUDAMED
M8275053/5 M8275053/10 GUDID
Primary DI / UDI-DI
00197998300912
Basic UDI-DI
084955408401010000000025X
FDA Product Code
OMP
EMDN Code
M040499 Dressings for wounds, sores and ulcerations - other
GMDN Term
Negative-pressure wound therapy system foam dressing, non-antimicrobial
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4780
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
M8275053/10 M8275053/5
GUDID
M8275053/5 M8275053/10
Device ClassEUDAMED
Class IIb
GUDID
Class II

Other devices from Kci USA, Inc.

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Properties

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