Eu Mdd
Eu Md Class 2a
No Longer On The Market
🇮🇳 India
SPICTRA
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 08906172230073
- Basic UDI-DI Code
- B-08906172230073
- Reference
- M20MP
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- No Longer On The Market
- Manufacturer
- MEDIHUB SCIENCETEC PRIVATE LIMITED
Additional Description
Myocardial Protection System intended for short term use consisting of a heat exchange system used in extra-corporeal circulation to warm or cool the blood or perfusion fluid flowing through the device and it is used to stop the beating of heart and to preserve the myocardium cells during Open-heart surgery (<6 hours), cooled crystalloid solution with or without blood mixture need to be transfused. The Blood-crystalloid mixture is prepared and circulated online
CND Nomenclature Codes
| Code | Description |
|---|---|
| C030102 | CARDIOPLEGIA SOLUTION ADMINISTRATION KITS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex V | 00-68/qpz-dm/247-2020 | MTIC InterCert S.r.l. | Expired |
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