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Ophthalmic Surgical System Cv-9000r
EUDAMEDClass IIb (EU MDR)
Ref Cubeα_B01E001Model CV-9000
Identity
- Trade Name
- OPHTHALMIC SURGICAL SYSTEM CV-9000R EUDAMED
- Model / Reference
- CV-9000 EUDAMEDCubeα_B01E001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987669101629 EUDAMED
- Basic UDI-DI
- 4987669222GA EUDAMED
- EMDN Code
- Z1212020785 PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye 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-9000r by Nidek Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Phacoemulsification system handpiece tip, single-use.
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- Constellation — Alcon Laboratories, Inc. · Class IIb
- 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 | 4987669222GA | 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 c227088c-fcee-46ff-818a-506f0c4b376f 61 fields · synced Aug 3, 2026