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[P. Koch] Nucleus Chopper, angled
EUDAMEDClass IIa (EU MDR)
Ref 8209Model Manual Handled Instruments
Identity
- Trade Name
- [P. Koch] Nucleus Chopper, angled EUDAMED
- Model / Reference
- Manual Handled Instruments EUDAMED8209 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840516107103 EUDAMED
- Basic UDI-DI
- 08405161820063 EUDAMED
- EMDN Code
- Q021108 OPHTHALMIC SURGERY PROBES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
[P. Koch] Nucleus Chopper, angled by Psi/Eye-Ko, Inc. — 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 | 08405161820063 | Class IIa | Active |
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Manufacturer
- Manufacturer
- PSI/EYE-KO, Inc.
- EUDAMED SRN
- US-MF-000022109
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 5f9e6d3b-19f6-4df4-9d89-a200b0174ff0 61 fields · synced Jul 19, 2026