Eu Mdd
Eu Md Class 2b
On The Market
🇰🇷 South Korea
HYDROGEN PEROXIDE CARTRIDGES
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- 08800066500016
- Basic UDI-DI Code
- B-08800066500016
- Reference
- STERMATE
- Device Types
-
Single use
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Plasmapp Co., Ltd
Additional Description
- The STERPACK contains hydrogen peroxide and is a consumable used together with the medical device, the STERLINK plus, and STERLINK mini product. - The STERPACK is a group of STERMATE that is designed to be used only by STERLINK plus and STERLINK mini sterilizer product, which is a low-temperature plasma sterilization system. - The STERPACK is intended for use in the processing of critical and semi-critical medical devices that are to be used on humans.
CND Nomenclature Codes
| Code | Description |
|---|---|
| S900101 | HYDROGEN PEROXIDE CARTRIDGES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 0068/QCO-DM/056-2019 | MTIC InterCert S.r.l. |
Available In Countries
🇩🇪 Germany
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