Basic UDI-DI
Eu Mdd
Eu Md Class 2b
🇺🇸 United States
Spatz3 Adjustable Balloon System Insertion Kit
Code: B-00860005178810
Devices
1
Certificates
1
Notified Bodies
1
Auth. Representatives
2
Basic Information
- UDI-DI Code
- B-00860005178810
- Issuing Agency
- EUDAMED
- Device Model
- A-SP3-03K
- Types
-
Implantable
- Regulation
- Eu Mdd Legacy
- Classification
- Eu Md Class 2b
- Manufacturer
- Spatz FGIA Inc.
- Last Updated
- January 19, 2022
Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
| Type | Number | Expiry Date | Status | |
|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 170222 QS/NB | INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390 | May 26, 2024 |
Associated Devices
This Basic UDI-DI is associated with 1 device.
| Name | Status |
|---|---|
| Spatz3 Adjustable Balloon System | On the market |