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Laparoscope
EUDAMEDFDA UDIClass I (EU MDR)
Ref 4KA30RModel 4KA0 4KA0R 4KA30 4KA30R 4KA45 4KA45R 4KA0F 4KA30F 4KA45F 4KA0F1 4KA30F1 4KA45F1 4KA0R1 4KA30R1 4KA45R1Ref 4KA45R1Ref 4KA0FRef 4KA45FRef 4KA30F
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 EUDAMED4KA30R EUDAMEDFDA UDI4KA45R1 EUDAMED4KA0F EUDAMED4KA45F EUDAMED4KA30F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975202770355 EUDAMEDFDA UDI06975202770461 EUDAMED06975202770386 EUDAMED06975202770409 EUDAMED06975202770393 EUDAMED
- 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 — 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 | 697520277004J5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (6)
- EUDAMED 1d6fa438-8f1e-4538-b8d0-500985f2b5aa 61 fields · synced Jul 30, 2026
- EUDAMED e459e4c9-75cf-4072-b713-d4c6a3691a9f 61 fields · synced May 17, 2026
- EUDAMED ed03e51f-6207-496e-ba9f-c74fdb8d4780 61 fields · synced May 17, 2026
- EUDAMED f3a4e743-d60b-411b-8731-e65c96f1e8a3 61 fields · synced May 17, 2026
- EUDAMED 15c16df8-e67f-4202-888f-f9f150b8387d 61 fields · synced May 18, 2026
- FDA UDI 4a3e6ae6-2ba3-4972-9a8f-cbf6a3923a31 33 fields · synced May 30, 2026