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General Surgery Tubing Sets

EUDAMED

Class IIa (EU MDR)

Ref WA95005A

by Promepla SAM

Identity

Device Name
General Surgery Tubing Sets EUDAMED
Model / Reference
WA95005A EUDAMED

Identifiers

Primary DI / UDI-DI
03700512925088 EUDAMED
Basic UDI-DI
037005129GSU-IEXH EUDAMED
EMDN Code
Z12029008 GAS INFLATORS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany 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

General Surgery Tubing Sets by Promepla SAM — 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
Promepla SAM
EUDAMED SRN
MC-MF-000015769
Authorised Representative
Promepla Group S.à r.l. LU-AR-000013458

Sources (1)

  • EUDAMED 66c10ae2-5d12-4c47-8fec-06ad5116e8a5 61 fields · synced Jun 18, 2026