Devices (same UDI-DI)
1
Certificates
1
Countries
11
Notified Bodies
1
Basic Information
- Primary DI
- 07290014930001
- Basic UDI-DI Code
- B-07290014930001
- Reference
- ASS‐35‐102
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- IOPtima Ltd.
Additional Description
The IOPtiMate™ is an accessory device, intended for use in conjunction with a medical grade CO2 laser for the CO2 Laser Assisted Sclerectomy Surgery (CLASS).
CND Nomenclature Codes
| Code | Description |
|---|---|
| Q0299 | OPHTHALMIC DEVICES - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 2125546CE01 | DEKRA Certification B.V. | Expired |
Available In Countries
🇨🇿 Czechia
🇩🇪 Germany
🇪🇸 Spain
🇫🇷 France
🇭🇺 Hungary
🇮🇹 Italy
🇱🇹 Lithuania
🇵🇱 Poland
🇵🇹 Portugal
🇷🇴 Romania
🇹🇷 Türkiye
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