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Laparoscope
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 4KA45RModel 4KA0 4KA0R 4KA30 4KA30R 4KA45 4KA45R 4KA0F 4KA30F 4KA45F 4KA0F1 4KA30F1 4KA45F1 4KA0R1 4KA30R1 4KA45R1
Identity
- Trade Name
- Laparoscope EUDAMEDEndoso FDA UDI
- Generic Name
- Rigid optical laparoscope FDA UDI
- Device Name
- Laparoscope EUDAMED
- Model / Reference
- 4KA0 4KA0R 4KA30 4KA30R 4KA45 4KA45R 4KA0F 4KA30F 4KA45F 4KA0F1 4KA30F1 4KA45F1 4KA0R1 4KA30R1 4KA45R1 EUDAMED4KA45R EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975202770379 EUDAMEDFDA UDI
- Basic UDI-DI
- 697520277004J5 EUDAMED
- 510(k) Number
- K231725 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- Z12029009 LAPAROSCOPES EUDAMED
- GMDN Term
- Rigid optical laparoscope FDA UDI
Classification
- Device Class
- Class I 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
Yes
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
No
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
Laparoscope by Hunan Endoso Life Technology Co., Ltd — Class I — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231725 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697520277004J5 | Class I | Active |
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Manufacturer
- Manufacturer
- Hunan Endoso Life Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000021400
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (3)
- EUDAMED 19dfc68c-1755-4f37-90ae-fa309b7fb9e0 61 fields · synced Jul 9, 2026
- FDA UDI cf809c4d-3bbd-4d37-8c65-95a38c29d3d6 33 fields · synced May 30, 2026
- FDA 510(k) K231725 1 fields · synced May 18, 2026