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4K UHD Laparoscope
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 4K1030RModel 4K5500(&R),4K5530(&R),4K5545(&R),4K1000(&R),4K1030(&R),4K1045(&R),4K1000L(&LR),4K1030L(&LR),4K1045L(&LR),4K5500L(&LR)，4K5530L(&LR)，4K5545L(&LR)
Identity
- Trade Name
- 4K UHD Laparoscope EUDAMEDFDA UDI
- Generic Name
- Rigid optical laparoscope FDA UDI
- Device Name
- 4K UHD Laparoscope EUDAMEDThe product is composed of eyepiece, lens body, optic fiber interface.The 4K UHD Laparoscope is intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications. FDA UDI
- Model / Reference
- 4K5500(&R),4K5530(&R),4K5545(&R),4K1000(&R),4K1030(&R),4K1045(&R),4K1000L(&LR),4K1030L(&LR),4K1045L(&LR),4K5500L(&LR)，4K5530L(&LR)，4K5545L(&LR) EUDAMED4K1030R EUDAMEDFDA UDI
- Description
- The product is composed of eyepiece, lens body, optic fiber interface.The 4K UHD Laparoscope is intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971381250268 EUDAMEDFDA UDI
- Basic UDI-DI
- 697138125004A88 EUDAMED
- Direct Marketing DI
- 06971381250268 EUDAMED
- FDA Product Code
- HET FDA UDINMH FDA UDIGCJ 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
- 884.1720 FDA UDI876.1500 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
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
4K UHD Laparoscope by Scivita Medical Technology Co., Ltd. — 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 | 697138125004A88 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Scivita Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010305
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 4c2b7a31-04fe-4d2d-9af4-80fe429509d4 61 fields · synced Jun 18, 2026
- FDA UDI 95544183-818a-4b28-89f5-952af13dce3a 35 fields · synced May 30, 2026