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Single-use Hystero Videoscope
EUDAMEDClass IIa (EU MDR)
Ref SHV-6830LNModel SHV-4800, SHV-6800, SHV-4830, SHV-4830L, SHV-4830N, SHV-4830LN, SHV-6830, SHV-6830L, SHV-6830N, SHV-6830LN, SHV-5830, SHV-5830L, SHV-5830N, SHV-5830LNRef SHV-P1Model SHV-B1,SHV-P1,SHV-B2,SHV-P2Ref SHV-6830NRef SHV-4800Ref SHV-5830LNRef SHV-4830LRef SHV-S2Model SHV-S1，SHV-S2
Identity
- Trade Name
- Single-use Hystero Videoscope EUDAMED
- Device Name
- Single-use Hystero Videoscope EUDAMED
- Model / Reference
- SHV-4800, SHV-6800, SHV-4830, SHV-4830L, SHV-4830N, SHV-4830LN, SHV-6830, SHV-6830L, SHV-6830N, SHV-6830LN, SHV-5830, SHV-5830L, SHV-5830N, SHV-5830LN EUDAMEDSHV-6830LN EUDAMEDSHV-B1,SHV-P1,SHV-B2,SHV-P2 EUDAMEDSHV-P1 EUDAMEDSHV-6830N EUDAMEDSHV-4800 EUDAMEDSHV-5830LN EUDAMEDSHV-4830L EUDAMEDSHV-S1，SHV-S2 EUDAMEDSHV-S2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971381257281 EUDAMED06971381254600 EUDAMED06971381250824 EUDAMED06971381257274 EUDAMED06971381253726 EUDAMED06971381259605 EUDAMED06971381257199 EUDAMED06971381253757 EUDAMED
- Basic UDI-DI
- 697138125029A8Z EUDAMED697138125012A87 EUDAMED697138125030A8B EUDAMED
- Direct Marketing DI
- 06971381257281 EUDAMED06971381254600 EUDAMED06971381250824 EUDAMED06971381257274 EUDAMED06971381253726 EUDAMED06971381259605 EUDAMED06971381257199 EUDAMED06971381253757 EUDAMED
- EMDN Code
- Z12020712 VIDEO HYSTEROSCOPES EUDAMEDZ12020704 HYSTEROSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Single-use Hystero Videoscope by Scivita Medical Technology 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 | 697138125029A8Z | Class IIa | Active |
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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 (8)
- EUDAMED 8dc83abb-6928-4360-980e-dddd53149cbc 61 fields · synced Sep 18, 2026
- EUDAMED 709f5d29-9dec-47ba-aec6-1ff55a8af3d4 61 fields · synced May 16, 2026
- EUDAMED 55165786-a359-4a43-8aa5-bd23de3b0b8b 61 fields · synced May 17, 2026
- EUDAMED f659db3f-8d9a-4331-91b2-9814a056717a 61 fields · synced May 18, 2026
- EUDAMED 2dd3459b-5688-413b-b453-d9b367139cba 61 fields · synced May 18, 2026
- EUDAMED fedc59e7-f80f-4117-89c2-d3c4323c418f 61 fields · synced May 18, 2026
- EUDAMED 64403839-dc49-4875-bcc7-f5ffe4f09f91 61 fields · synced May 18, 2026
- EUDAMED 251e5867-f7c6-48cc-9b7c-b940529a040c 61 fields · synced May 18, 2026