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Solventum™ V.A.C.® Granufoam™

by KCI USA Inc.

Ref M8275051/5 M8275051/10 M8275051/5

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00197998301360 UDI-DI Date7 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number084955408401010000000025X Basic UDI-DI 00197998301360UDI-DIDate23 Jul 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  • Withdrawn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

Generic Name
Negative-pressure wound therapy system foam dressing, non-antimicrobial
Device Name
Solventum MDR V.A.C. Granufoam Dressing Kits
Model / Ref / Catalog
M8275051/5 M8275051/10 M8275051/5 EUDAMED
M8275051/5 M8275051/10 GUDID
Primary DI / UDI-DI
00197998301360
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
M8275051/5 M8275051/10 M8275051/5
GUDID
M8275051/5 M8275051/10
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000016844
Authorised representative
KCI Manufacturing Unlimited Company IE-AR-000016082

Other devices from Kci USA, Inc.

See all devices from Kci USA, Inc. →

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