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Phaco Set Sophi – 21G/Curved
EUDAMEDClass IIa (EU MDR)
Ref 1401-2721
by Medicel AG
Identity
- Trade Name
- Phaco Set Sophi – 21G/Curved EUDAMED
- Device Name
- Phaco Accessories Set EUDAMED
- Model / Reference
- 1401-2721 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630055242136 EUDAMED
- Basic UDI-DI
- 076300552PASU033D EUDAMED
- Direct Marketing DI
- 07630055242136 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
Phaco Set Sophi – 21G/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 bc7e7ef7-300c-4e4b-8211-b3514ab83dab 61 fields · synced Oct 6, 2026