Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Rigid optical laparoscope FDA UDI
- Device Name
- Laparoscope 10 x 344 mm, 0°, NIR FDA UDI
- Model / Reference
- Laparoscopes EUDAMED11-0131nir EUDAMEDFDA UDI
- Description
- Laparoscope 10 x 344 mm, 0°, NIR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250480102046 EUDAMED04250480109052 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504801LAPAROSCOPESEF EUDAMED
- Direct Marketing DI
- 04250480102046 EUDAMED04250480109052 EUDAMED
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- Z12029009 LAPAROSCOPES EUDAMED
- GMDN Term
- Rigid optical laparoscope FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass 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
MR Unsafe FDA UDI
11-0131nir 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42504801LAPAROSCOPESEF | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Schölly Fiberoptic Gmbh
- EUDAMED SRN
- DE-MF-000005618
Sources (3)
- EUDAMED e9decae2-aa4e-42ff-b22f-63aebfe64d9d 61 fields · synced Jul 23, 2026
- EUDAMED a4081b41-9071-48e8-9b6f-eb69f2f340e9 61 fields · synced May 19, 2026
- FDA UDI 2d3b0920-836d-40ee-8348-9c8330d01c47 36 fields · synced May 24, 2026