EU Manufacturer
๐บ๐ธ United States
Active
Spatz FGIA Inc.
SRN: US-MF-000012214
ยท
1801 S Perimeter Road STE 130, 33309 Fort Lauderdale, United States
Basic UDI-DIs
1
Total Devices
1
On Market
1
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
20
Basic Information
- Address
- 1801 S Perimeter Road STE 130, 33309 Fort Lauderdale, United States
- [email protected]
- Website
- www.spatzmedical.com
Regulatory Overview
Regulation
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Eu Mdd
1
Classification
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Eu Md Class 2b
1
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 170222 QS/NB | INSTITUT PRO TESTOVรNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390 | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 20 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ญ๐บ Hungary
๐ฎ๐น Italy
๐ฑ๐ป Latvia
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Spatz3 Adjustable Balloon System | EU MDD | Eu Md Class 2b | On Market | 1 |