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ERGOJECT PRO 1.6 Injector
EUDAMEDClass IIa (EU MDR)
Ref ERP1600Model IOL injectors
by Medicel AG
Identity
- Trade Name
- ERGOJECT PRO 1.6 Injector EUDAMED
- Device Name
- IOL injectors EUDAMED
- Model / Reference
- IOL injectors EUDAMEDERP1600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630055213594 EUDAMED
- Basic UDI-DI
- 076300552INJ01YD EUDAMED
- Direct Marketing DI
- 07630055213594 EUDAMED
- EMDN Code
- Q021111 OCULAR IMPLANT INSTRUMENTS, SINGLE-USE 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
ERGOJECT PRO 1.6 Injector 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 | 076300552INJ01YD | 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 0bc2f5e6-d0fe-41f7-b449-0de17dad8d12 61 fields · synced Oct 6, 2026