Eu Mdd
Eu Md Class 3
On The Market
๐บ๐ธ United States
Optilume
Devices (same UDI-DI)
1
Certificates
1
Countries
16
Notified Bodies
1
Basic Information
- Primary DI
- 00853095008792
- Basic UDI-DI Code
- B-00853095008792
- Reference
- 1110-08030C
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Urotronic, Inc.
Additional Description
Urethral Drug Coated Balloon Catheter
CND Nomenclature Codes
| Code | Description |
|---|---|
| U0399 | DEVICES FOR URINARY TRACT DILATION - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | 1434-MDD-033/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐น Portugal
๐ธ๐ช Sweden
๐ฌ๐ง United Kingdom
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