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Romo Vac Set

by Romsons International (Unit II) India EUDAMED

Ref GS-5002S

EMDN A0601010103

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8902120G001SJ Basic UDI-DIDate4 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Closed Wound Drainage System
Model / Reference
GS-5002S
Primary DI / UDI-DI
08902120500250, 08902120500212
Basic UDI-DI
8902120G001SJ
EMDN Code
A0601010103 Bellows drainage systems
Device Class
Class IIa
Market of Registration
Italy
Türkiye

Manufacturer details

EUDAMED SRN
IN-MF-000024594
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Romsons International (Unit II)

See all devices from Romsons International (Unit II) →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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

Sources (2)

  • EUDAMED c74dbd0b-f16d-43d8-8688-7017eb7ede6d 61 fields · synced 22 Oct 2026
  • EUDAMED 08902120500212|8902120G001SJ 61 fields · synced 17 May 2026