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Exxacta

EUDAMED

Class IIa (EU MDR)

Ref GS-3146Ref GS-3150

by Romsons International (Unit II)

Identity

Trade Name
EXXACTA EUDAMED
EXXACTA MARVEL EUDAMED
Device Name
Three way stop cock EUDAMED
Model / Reference
GS-3146 EUDAMED
GS-3150 EUDAMED

Identifiers

Primary DI / UDI-DI
08902120314604 EUDAMED
08902120315007 EUDAMED
Basic UDI-DI
8902120C005RW EUDAMED
EMDN Code
A0703 STOPCOCKS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Italy EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Exxacta by Romsons International (Unit II) — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

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

Sources (2)

  • EUDAMED 5ad3ba02-5657-406e-bd0a-2ae94710881d 61 fields · synced Jul 14, 2026
  • EUDAMED 7dfd9eb8-a71b-48d4-bc07-4f6ab01e012f 61 fields · synced May 18, 2026