EU Manufacturer
๐บ๐ธ United States
Active
Graham Medical Technologies, LLC dba GraMedica
SRN: US-MF-000008507
ยท
Leone Drive 16137 , 48042 Macomb, United States
Basic UDI-DIs
1
Total Devices
1
On Market
1
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
19
Basic Information
- Address
- Leone Drive 16137 , 48042 Macomb, United States
- [email protected]
- Phone
- +001 586-677-9600
- Website
- www.gramedica.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Expired / Withdrawn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) | US19/819943475 | SGS Belgium NV | Jun 04, 2023 |
Market Presence
Devices from this manufacturer are available in 19 countries across Europe.
๐ฆ๐น Austria
๐ง๐ฌ Bulgaria
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ญ๐บ Hungary
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฑ๐ป Latvia
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| HyProCure Sinus Tarsi Implant | EU MDD | Eu Md Class 2b | On Market | 1 |