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4K S-Sonic 21G/30° Curved
EUDAMEDClass IIa (EU MDR)
Ref PA603540C
by Medicel AG
Identity
- Trade Name
- 4K S-Sonic 21G/30° Curved EUDAMED
- Device Name
- Phaco Accessories Set EUDAMED
- Model / Reference
- PA603540C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630055243041 EUDAMED
- Basic UDI-DI
- 076300552PASU033D EUDAMED
- Direct Marketing DI
- 07630055243041 EUDAMED
- EMDN Code
- Q020699 PHACOEMULSIFICATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
4K S-Sonic 21G/30° Curved by Medicel AG — 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 | 076300552PASU033D | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medicel AG
- EUDAMED SRN
- CH-MF-000016652
- Authorised Representative
- Rudolf Riester GmbH DE-AR-000015844
Sources (1)
- EUDAMED 8532f2cc-5493-4899-9a4c-6a7d8a9ce3ac 61 fields · synced Oct 6, 2026