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VISCOJECT-BIO 1.8 Injector Set
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref LP604350CModel IOL injectors
by Medicel AG
Identity
- Trade Name
- VISCOJECT-BIO 1.8 Injector Set EUDAMED
- Device Name
- IOL injectors EUDAMED
- Model / Reference
- IOL injectors EUDAMEDLP604350C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630055214799 EUDAMED07630055212214 EUDAMED07630055213891 EUDAMED07630055214041 EUDAMED
- Basic UDI-DI
- 076300552INJ01YD EUDAMED
- Direct Marketing DI
- 07630055214799 EUDAMED07630055212214 EUDAMED07630055213891 EUDAMED07630055214041 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
VISCOJECT-BIO 1.8 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 | K070669 | 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 (5)
- EUDAMED 934bc987-30c0-407f-9353-50a5cec3ec44 61 fields · synced Oct 6, 2026
- EUDAMED 80b996b5-d622-4950-815e-85840c7b5ea0 61 fields · synced May 19, 2026
- EUDAMED 74fa403d-575e-43cd-8036-b817c1b9c7dc 61 fields · synced May 19, 2026
- EUDAMED 8a168ccb-07f6-420f-86d4-d30340db2fb0 61 fields · synced May 19, 2026
- FDA 510(k) K070669 1 fields · synced May 18, 2026