EU Manufacturer
🇨🇳 China
Active
Henan Simedice Biotechnologies Co.,Ltd.
SRN: CN-MF-000017957
·
No. 28, Floor 7, Unit A, Building 1, No. 8 Guohuai Ave., 450001 Zhengzhou, Henan, China
Basic UDI-DIs
3
Total Devices
3
On Market
3
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
1
Basic Information
- Address
- No. 28, Floor 7, Unit A, Building 1, No. 8 Guohuai Ave., 450001 Zhengzhou, Henan, China
- [email protected]
- Phone
- +86-371-55635672
- Website
- www.simedice.com
Regulatory Overview
Regulation
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Eu Mdd
3
Classification
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Eu Md Class 2b
3
Device Types
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Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 6085114CE01 | DEKRA Certification B.V. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | M.2021.106.14254 | UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. | May 27, 2024 |
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
🇮🇹 Italy
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC | EU MDD | Eu Md Class 2b | On Market | 1 |
| IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC | EU MDD | Eu Md Class 2b | On Market | 1 |
| IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC | EU MDD | Eu Md Class 2b | On Market | 1 |