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Zentrum BiCare

by Mrk Healthcare Pvt. Ltd. India EUDAMED

Ref SRGLPE EMDN T01010101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8905159SRGLPWCB Basic UDI-DIDate29 Jul 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Latex Surgical Gloves, Powdered
Model / Reference
SRGLPE
Primary DI / UDI-DI
08905159010424, 08905159010417, 08905159010363, 08905159010370, 08905159010387, 08905159010394, 08905159010400, 08905159010356
Basic UDI-DI
8905159SRGLPWCB
EMDN Code
T01010101 Powdered latex surgical gloves
Device Class
Class IIa
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
IN-MF-000019843
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Mrk Healthcare Pvt. Ltd.

  • Nulife

    Class IIa

  • Brp

    Class I

  • Alfashield

    Class IIa

  • Galena

    Class I

  • Nulife

    Class IIa

  • Nulife

    Class IIa

See all devices from Mrk Healthcare Pvt. Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Contains Latex
Other properties (11)
  • Implantable: No
  • Reusable: 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

Sources (8)

  • EUDAMED c1694bb0-3e0a-4098-b277-a96be2f0dc6e 61 fields · synced 22 Oct 2026
  • EUDAMED 08905159010417|8905159SRGLPWCB 61 fields · synced 17 May 2026
  • EUDAMED 08905159010363|8905159SRGLPWCB 61 fields · synced 17 May 2026
  • EUDAMED 08905159010370|8905159SRGLPWCB 61 fields · synced 17 May 2026
  • EUDAMED 08905159010387|8905159SRGLPWCB 61 fields · synced 19 May 2026
  • EUDAMED 08905159010394|8905159SRGLPWCB 61 fields · synced 19 May 2026
  • EUDAMED 08905159010400|8905159SRGLPWCB 61 fields · synced 19 May 2026
  • EUDAMED 08905159010356|8905159SRGLPWCB 61 fields · synced 19 May 2026