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VISCOJECT 1.8 Injector Set
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref LP604350Model IOL injectors
by Medicel AG
Identity
- Trade Name
- VISCOJECT 1.8 Injector Set EUDAMEDFDA UDI
- Generic Name
- Manual intraocular lens injector, single-use FDA UDI
- Device Name
- IOL injectors EUDAMEDInjectors and cartridges for the injection of intraocular lenses (IOL) into the eye during surgical procedures. FDA UDI
- Model / Reference
- IOL injectors EUDAMEDLP604350 EUDAMEDFDA UDI
- Description
- Injectors and cartridges for the injection of intraocular lenses (IOL) into the eye during surgical procedures. FDA UDI
Identifiers
- Catalog Number
- LP604350 FDA UDI
- Primary DI / UDI-DI
- 07630055213884 EUDAMED07630055211941 EUDAMEDFDA UDI
- Basic UDI-DI
- 076300552INJ01YD EUDAMED
- Direct Marketing DI
- 07630055213884 EUDAMED07630055211941 EUDAMED
- FDA Product Code
- MSS FDA UDI
- EMDN Code
- Q021111 OCULAR IMPLANT INSTRUMENTS, SINGLE-USE EUDAMED
- GMDN Term
- Manual intraocular lens injector, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
VISCOJECT 1.8 Injector Set by Medicel AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 076300552INJ01YD | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Medicel AG
- EUDAMED SRN
- CH-MF-000016652
- Authorised Representative
- Rudolf Riester GmbH DE-AR-000015844
Sources (3)
- EUDAMED 46bbabe1-74c3-403a-991d-817f2521a167 61 fields · synced Oct 6, 2026
- EUDAMED a23c5ae3-40b5-4ab3-a924-a28665877c9b 61 fields · synced May 18, 2026
- FDA UDI 76d6e3bf-65ee-44f5-b78b-878f6b7ce69d 35 fields · synced May 30, 2026