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ACCUJECT REFRA 2.9 Injector
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref AR2900Model IOL injectors
by Medicel AG
Identity
- Trade Name
- ACCUJECT REFRA 2.9 Injector EUDAMEDFDA UDI
- Generic Name
- Manual intraocular lens injector, single-use FDA UDI
- Device Name
- IOL injectors EUDAMED
- Model / Reference
- IOL injectors EUDAMEDAR2900 EUDAMEDREV.P FDA UDI
Identifiers
- Catalog Number
- AR2900 FDA UDI
- Primary DI / UDI-DI
- 07630055214850 EUDAMEDFDA UDI
- Basic UDI-DI
- 076300552INJ01YD EUDAMED
- Direct Marketing DI
- 07630055214850 EUDAMED
- 510(k) Number
- K231106 FDA UDI
- 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
No
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
Yes
FDA UDI
ACCUJECT REFRA 2.9 Injector by Medicel AG — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, 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 | K231106 | 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 (3)
- EUDAMED 76768164-e787-4195-9417-6765c7d5e703 61 fields · synced Jun 18, 2026
- FDA UDI 071f9831-c264-4a88-a32f-f568c3b6292a 34 fields · synced May 30, 2026
- FDA 510(k) K231106 1 fields · synced May 18, 2026