← Back to catalogue
Intraocular Lens
EUDAMEDClass IIb (EU MDR)
Ref SM60ASRef SM60AS2Model SM60AS, SM60AS1, SM60AS2, SM60AS3Ref SM60AS3
Identity
- Device Name
- Intraocular Lens EUDAMED
- Model / Reference
- SM60AS EUDAMEDSM60AS, SM60AS1, SM60AS2, SM60AS3 EUDAMEDSM60AS2 EUDAMEDSM60AS3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974200250005 EUDAMED06974200255420 EUDAMED06974200255840 EUDAMED06974200255826 EUDAMED06974200255482 EUDAMED
- Basic UDI-DI
- B-06974200250005 EUDAMED697420025P030102090201V7 EUDAMED
- Direct Marketing DI
- 06974200255420 EUDAMED06974200255840 EUDAMED06974200255826 EUDAMED06974200255482 EUDAMED
- EMDN Code
- P030102090201 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
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
Intraocular Lens by Henan Simedice Biotechnologies Co., Ltd. — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06974200250005 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06974200250005 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Henan Simedice Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000017957
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (5)
- EUDAMED 2fb64d23-5384-47a8-ad80-26f3ac1e01ba 61 fields · synced Sep 17, 2026
- EUDAMED 20c6f9b1-28f0-4ba1-b6d0-250198f6e4ed 61 fields · synced Jul 8, 2026
- EUDAMED 1a24c6b0-246c-490a-b551-37ea067c67ab 61 fields · synced Jul 8, 2026
- EUDAMED a6c97963-7451-4d8f-bb63-da9617035e48 61 fields · synced Jul 8, 2026
- EUDAMED f94796e1-c9bb-4117-8de2-4e5c7993b5b3 61 fields · synced Jul 8, 2026