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11.0041a

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 11.0041aModel Laparoscopes

by Schölly Fiberoptic Gmbh

Identity

Trade Name
NA FDA UDI
Generic Name
Rigid optical laparoscope FDA UDI
Device Name
Laparoscope 10 x 344 mm, 45° FDA UDI
Model / Reference
Laparoscopes EUDAMED
11.0041a EUDAMEDFDA UDI
Description
Laparoscope 10 x 344 mm, 45° FDA UDI

Identifiers

Primary DI / UDI-DI
04250480100882 EUDAMEDFDA UDI
Basic UDI-DI
42504801LAPAROSCOPESEF EUDAMED
Direct Marketing DI
04250480100882 EUDAMED
FDA Product Code
GCJ FDA UDI
EMDN Code
Z12029009 LAPAROSCOPES EUDAMED
GMDN Term
Rigid optical laparoscope FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
876.1500 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

11.0041a by SCHÖLLY FIBEROPTIC GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Schölly Fiberoptic Gmbh
EUDAMED SRN
DE-MF-000005618

Sources (3)

  • EUDAMED e98cc503-827c-4314-aba6-2be3ae02a66d 61 fields · synced Jul 18, 2026
  • FDA UDI d6a04c19-9077-411a-9000-23d43025e85a 36 fields · synced May 25, 2026
  • FDA 510(k) K143221 1 fields · synced May 18, 2026