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Ophthalmic Surgical System Cv-30000
EUDAMEDClass IIb (EU MDR)
Ref Fortas_B01E007Model CV-30000
Identity
- Trade Name
- OPHTHALMIC SURGICAL SYSTEM CV-30000 EUDAMED
- Model / Reference
- CV-30000 EUDAMEDFortas_B01E007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987669101773 EUDAMED
- Basic UDI-DI
- 4987669221G8 EUDAMED
- EMDN Code
- Z1212020785 PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
No
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
Category: Phacoemulsification system handpiece tip, single-use
Ophthalmic Surgical System Cv-30000 by Nidek Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Phacoemulsification system handpiece tip, single-use.
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- AMO PHACO NEEDLE — Johnson & Johnson Surgical Vision, Inc. · Class II
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 | 4987669221G8 | Class IIb | Active |
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Manufacturer
- Manufacturer
- NIDEK.CO.Ltd.,
- EUDAMED SRN
- JP-MF-000040151
- Authorised Representative
- NIDEK SA FR-AR-000000341
Sources (1)
- EUDAMED e3f3ce32-4ff5-42fa-9229-2d1ba3b2f4c4 61 fields · synced Jul 30, 2026