Eu Mdd
Eu Md Class 1
On The Market
🇺🇸 United States
Uromedica ACT/ProACT Implantation Instrument Set
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00180668000243
- Basic UDI-DI Code
- B-00180668000243
- Reference
- 750009
- Device Types
-
Sterilization
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 1
- Status
- On The Market
- Manufacturer
- Uromedica, Incorporated
Additional Description
A reusable, steam sterilizable Implantation Instrument Set consisting of a U-channel sheath through which the ACT/ProACT implant is introduced, and a removable internal trocar with a sharpened tip for penetrating the tissue.
CND Nomenclature Codes
| Code | Description |
|---|---|
| L99 | SURGICAL INSTRUMENTS, REUSABLE - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | Q5 045789 0019 | TÜV SÜD Product Service GmbH | Expired |
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