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Gelato

EUDAMED

Class IIa (EU MDR)

Ref GS-2025 PRef GS-2025 TC

by Romsons Group Private Limited

Identity

Trade Name
GELATO EUDAMED
Device Name
SUCTION CATHETER EUDAMED
Model / Reference
GS-2025 P EUDAMED
GS-2025 TC EUDAMED

Identifiers

Primary DI / UDI-DI
08907265000443 EUDAMED
08907265202564 EUDAMED
08907265202526 EUDAMED
08907265202502 EUDAMED
08907265000146 EUDAMED
08907265202519 EUDAMED
08907265202571 EUDAMED
08907265202557 EUDAMED
08907265000979 EUDAMED
08907265202588 EUDAMED
Basic UDI-DI
8907265B008YQ EUDAMED
EMDN Code
A06010103 CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Austria 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

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Gelato by Romsons Group Private Limited — 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

Manufacturer
Romsons Group Private Limited
EUDAMED SRN
IN-MF-000036506
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (10)

  • EUDAMED 255929db-4223-42f8-933d-e321a321fa5d 61 fields · synced Aug 1, 2026
  • EUDAMED f02ce0b4-42ea-4f84-aaaa-5dca5aa78ca9 61 fields · synced May 17, 2026
  • EUDAMED 3bf2be4b-633c-40b6-ab7f-8f159964d264 61 fields · synced May 17, 2026
  • EUDAMED c4188265-f2d0-449a-9c28-8e6784bcd984 61 fields · synced May 17, 2026
  • EUDAMED e7072722-a287-4769-a9ae-99f970fd5003 61 fields · synced May 17, 2026
  • EUDAMED e6ddc925-757b-4020-abe2-6278961623a7 61 fields · synced May 17, 2026
  • EUDAMED 8d43a87c-712a-4d7a-9d2d-9cdfbd0eef59 61 fields · synced May 19, 2026
  • EUDAMED e16a3470-795b-491a-b9f3-2ae1810f6261 61 fields · synced May 19, 2026
  • EUDAMED dfe8b06e-1aed-466d-9183-6cfac387fd5e 61 fields · synced May 19, 2026
  • EUDAMED 58780c91-c806-4ab8-aa90-83eeb39f2c9b 61 fields · synced May 19, 2026