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Disposable Bipolar Probe 18 Gauge, 36.2cm

EUDAMED

Class IIb (EU MDR)

Ref 1001-MDE 001

by Kirwan Surgical Products LLC

Identity

Device Name
Disposable Bipolar Probe 18 Gauge, 36.2cm EUDAMED
Model / Reference
1001-MDE 001 EUDAMED

Identifiers

Primary DI / UDI-DI
00841019119235 EUDAMED
Basic UDI-DI
B-00841019119235 EUDAMED
EMDN Code
K0201010501 OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Disposable Bipolar Probe 18 Gauge, 36.2cm by Kirwan Surgical Products Llc — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, single-use.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Kirwan Surgical Products LLC
EUDAMED SRN
US-MF-000008222
Authorised Representative
MPS Medical Product Service GmbH DE-AR-000005009

Sources (1)

  • EUDAMED 0c328c99-bfdb-4dcb-9672-7b31ab2547f9 61 fields · synced Jun 18, 2026