Eu Mdd
Eu Md Class 2a
On The Market
π¨π³ China
Apexus
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- 06955454120016
- Basic UDI-DI Code
- B-06955454120016
- Reference
- IIa
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Polyrey Medical Tech(Suzhou) Co., Ltd.
Additional Description
The Apexus PTA balloon dilatation catheter is compatible with 0.014" or 0.018" guide wire, 4Fr introducer and/or 6Fr guiding catheter, and is designed to be connected to an inflation device via hub for inflating the balloon, in order for vessel dilatation purpose.
CND Nomenclature Codes
| Code | Description |
|---|---|
| C010402020101 | PTA BALLOON DILATATION CATHETERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 7159GB410210115A | DNV MEDCERT GmbH | Expired |
Available In Countries
π©πͺ Germany
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