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Rl-130

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref RL-130Model Laparoscopes

by Schölly Fiberoptic Gmbh

Identity

Trade Name
NA FDA UDI
Generic Name
Rigid optical laparoscope FDA UDI
Device Name
Laparoscope 10 x 344mm, 30° RL-130 FDA UDI
Model / Reference
Laparoscopes EUDAMED
RL-130 EUDAMEDFDA UDI
Description
Laparoscope 10 x 344mm, 30° RL-130 FDA UDI

Identifiers

Primary DI / UDI-DI
04250480101766 EUDAMEDFDA UDI
Basic UDI-DI
42504801LAPAROSCOPESEF EUDAMED
Direct Marketing DI
04250480101766 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

Rl-130 by SCHÖLLY FIBEROPTIC GmbH — Class IIa — 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
Schölly Fiberoptic Gmbh
EUDAMED SRN
DE-MF-000005618

Sources (2)

  • EUDAMED 7019d1d5-bc7d-4939-be89-f34166089c30 61 fields · synced Jul 18, 2026
  • FDA UDI d1d61f48-6f2b-498e-a65f-b20c726f63c9 36 fields · synced May 30, 2026