Eu Mdd
Eu Md Class 3
On The Market
๐ธ๐ฌ Singapore
Bioptimal Bipolar Pacing Catheter
Devices (same UDI-DI)
1
Certificates
2
Countries
13
Notified Bodies
2
Basic Information
- Primary DI
- 08886483507104
- Basic UDI-DI Code
- B-08886483507104
- Reference
- BP-0002-007
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Bioptimal International PTE. LTD.
Additional Description
Catheter without balloon and with contamination shield
CND Nomenclature Codes
| Code | Description |
|---|---|
| C020201 | TEMPORARY ENDOCARDIAL LEADS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 2181711CE01 | DEKRA Certification B.V. | Expired |
| MDD Annex II Section 4 | 2181711DE03 | DEKRA Certification B.V. | Expired |
Available In Countries
๐ฆ๐น Austria
๐ง๐ฌ Bulgaria
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ท๐ด Romania
๐ธ๐ฐ Slovakia
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