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ACCUJECT 2.1-1P Injector Set
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref LP604590Model IOL injectors
by Medicel AG
Identity
- Trade Name
- ACCUJECT 2.1-1P Injector Set EUDAMED
- Device Name
- IOL injectors EUDAMED
- Model / Reference
- IOL injectors EUDAMEDLP604590 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630055214027 EUDAMED07630055214652 EUDAMED07630055212368 EUDAMED07630055214591 EUDAMED07630055214584 EUDAMED
- Basic UDI-DI
- 076300552INJ01YD EUDAMED
- Direct Marketing DI
- 07630055214652 EUDAMED07630055212368 EUDAMED07630055214591 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
ACCUJECT 2.1-1P Injector Set by Medicel AG — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252540 | Class IIa | Active |
| 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 (6)
- EUDAMED ed2b870e-b47e-41f6-a175-e328bd9e19eb 61 fields · synced Oct 6, 2026
- EUDAMED 7678413e-f0a0-45dd-9fb3-ee2b15d0de46 61 fields · synced May 17, 2026
- EUDAMED ee3b833a-6e1a-424b-a891-33721b3ada22 61 fields · synced May 18, 2026
- EUDAMED 5aaaedfd-dc81-48d9-954d-a4046919771d 61 fields · synced May 19, 2026
- EUDAMED 7fbf1e93-3e76-4d48-9e20-88e1e7324cf8 61 fields · synced May 19, 2026
- FDA 510(k) K252540 1 fields · synced May 18, 2026