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Laparoscope
EUDAMEDClass IIa (EU MDR)
Ref U8725Model DFRef JY0800SModel BFJ-1Ref J1800Ref J0800YModel YFJ-1
Identity
- Device Name
- Laparoscope EUDAMED
- Model / Reference
- DF EUDAMEDU8725 EUDAMEDBFJ-1 EUDAMEDJY0800S EUDAMEDJ1800 EUDAMEDYFJ-1 EUDAMEDJ0800Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971244212112 EUDAMED06971244212006 EUDAMED06971244212082 EUDAMED06971244211979 EUDAMED
- Basic UDI-DI
- 697124421FQJ0001BY EUDAMED697124421FQJ0002C2 EUDAMED697124421FQJ0003C4 EUDAMED
- EMDN Code
- L181003 ELECTROSURGERY CONNECTION CABLES, REUSABLE EUDAMEDZ12029009 LAPAROSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMEDNorthern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Laparoscope by Shenyang Shenda Endoscope Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697124421FQJ0001BY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenyang Shenda Endoscope Co., Ltd.
- EUDAMED SRN
- CN-MF-000030478
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (4)
- EUDAMED 292b96ea-0226-4733-8b97-e0f3d19c18ce 61 fields · synced Oct 6, 2026
- EUDAMED d378adb0-e327-45e4-ac0f-ebee612f7236 61 fields · synced May 16, 2026
- EUDAMED f5a3d445-c8dd-4a52-a33e-9aabe15df488 61 fields · synced May 17, 2026
- EUDAMED d20910a1-f816-4e73-be11-5d66c7f6b31a 61 fields · synced May 17, 2026