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Handle, size M, bipolar HICURA

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref WA69002M

by Olympus Winter & Ibe GmbH

Identity

Trade Name
Handle, size M, bipolar HICURA EUDAMED
Olympus FDA UDI
Generic Name
Surgical instrument handle, non-torque-limiting FDA UDI
Device Name
Hicura Handle - bipolar EUDAMED
Handle "HICURA", size M, bipolar FDA UDI
Model / Reference
WA69002M EUDAMEDFDA UDI
Description
Handle "HICURA", size M, bipolar FDA UDI

Identifiers

Catalog Number
WA69002M FDA UDI
Primary DI / UDI-DI
04042761078313 EUDAMEDFDA UDI
Basic UDI-DI
4042761110604W EUDAMED
Direct Marketing DI
04042761078313 EUDAMED
510(k) Number
K140624 FDA UDI
FDA Product Code
GEI FDA UDI
EMDN Code
L180302 ENDOSCOPIC ELECTROSURGERY HANDPIECES, REUSABLE EUDAMED
GMDN Term
Surgical instrument handle, non-torque-limiting FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Handle, size M, bipolar HICURA by Olympus Winter & Ibe GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Olympus Winter & Ibe GmbH
EUDAMED SRN
DE-MF-000006729

Sources (3)

  • EUDAMED 2ea5ce04-ba77-491a-8141-0905f4de49be 61 fields · synced Jul 15, 2026
  • FDA UDI 9be0fe38-0d46-4820-9f7d-0c8bcb6cca55 36 fields · synced May 30, 2026
  • EUDAMED 83ddacc0-fef1-40f4-bb59-e34b54ae9a85 61 fields · synced Jul 15, 2026