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Toric Intraocular Lens
EUDAMEDClass IIb (EU MDR)
Ref STModel ST1Ref ST3Model ST1, ST2, ST3, ST4, ST5, ST6, ST7, ST8, ST9,ST10Ref ST4Ref ST6Ref ST2Ref ST8Ref ST5Ref ST9
Identity
- Device Name
- Toric Intraocular Lens EUDAMED
- Model / Reference
- ST1 EUDAMEDST EUDAMEDST1, ST2, ST3, ST4, ST5, ST6, ST7, ST8, ST9,ST10 EUDAMEDST3 EUDAMEDST4 EUDAMEDST6 EUDAMEDST2 EUDAMEDST8 EUDAMEDST5 EUDAMEDST9 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974200252054 EUDAMED06974200250906 EUDAMED06976813261911 EUDAMED06976813262314 EUDAMED06974200252351 EUDAMED06974200251774 EUDAMED06976813262628 EUDAMED06976813262420 EUDAMED06974200250982 EUDAMED06976813263038 EUDAMED
- Basic UDI-DI
- B-06974200252054 EUDAMED697420025P030102090301VC EUDAMED
- Direct Marketing DI
- 06974200250906 EUDAMED06976813261911 EUDAMED06976813262314 EUDAMED06974200252351 EUDAMED06974200251774 EUDAMED06976813262628 EUDAMED06976813262420 EUDAMED06974200250982 EUDAMED06976813263038 EUDAMED
- EMDN Code
- P030102090301 IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Toric 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-06974200252054 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06974200252054 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Henan Simedice Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000017957
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (10)
- EUDAMED 69ded22d-4fb2-4364-980d-22a0215870bd 61 fields · synced Aug 1, 2026
- EUDAMED 585b107b-126d-4f76-adf5-08d228c816ce 61 fields · synced Jul 8, 2026
- EUDAMED 0d641ea5-e717-43bf-82db-5435c5a11d0b 61 fields · synced Jul 8, 2026
- EUDAMED 8f62bb0a-7041-4ab2-acac-dd6b67dc0bae 61 fields · synced Jul 8, 2026
- EUDAMED 9dcab222-5a98-4960-9b82-f89635d8d71b 61 fields · synced Jul 8, 2026
- EUDAMED 7eda2ae3-43ed-4f8b-9fc6-aa54d2259bbb 61 fields · synced Jul 8, 2026
- EUDAMED d67f2a23-d8dc-4a7c-aaf5-b39624379b1a 61 fields · synced Jul 8, 2026
- EUDAMED e4997b84-2504-4785-9d2f-d8c1d3f2cbbd 61 fields · synced Aug 1, 2026
- EUDAMED d20a3bec-83f1-41bb-ae99-66f04d232302 61 fields · synced Aug 1, 2026
- EUDAMED dae57635-ec0c-4d6e-9dd8-8ad3161897a3 61 fields · synced Aug 1, 2026