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Biogel® PI Micro Indicator® System 48355

by Mölnlycke Health Care AB

Ref 48355

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

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 Number733243000000000072JZ Basic UDI-DI 07323190139255UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07323190139255 UDI-DI Date2 Mar 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

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  • Withdrawn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
Biogel PI Micro Indicator System EUDAMED
Biogel® PI Micro Indicator® System GUDID
Generic Name
Polyisoprene surgical glove, non-powdered, non-antimicrobial
Device Name
Biogel Synthetic Sterile Surgical Gloves
Model / Reference
48355
Primary DI / UDI-DI
07323190139255
Basic UDI-DI
733243000000000072JZ
510(k) Number
FDA Product Code
KGO
EMDN Code
T01010203 Polyisopren surgical gloves
GMDN Term
Polyisoprene surgical glove, non-powdered, non-antimicrobial
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4460
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Cleared under the same submission (K141719)

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Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No