EU Manufacturer
🇹🇼 Taiwan
Active
Flat Medical Co., Ltd.
SRN: TW-MF-000002272
·
12F-2., No. 206, Sec. 2, Nanjing E. Rd., Zhongshan Dist.,, 104496 Taipei City, Taiwan
Basic UDI-DIs
4
Total Devices
4
On Market
4
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- 12F-2., No. 206, Sec. 2, Nanjing E. Rd., Zhongshan Dist.,, 104496 Taipei City, Taiwan
- [email protected]
- Phone
- +886-2-25672959
- Website
- www.flatmedical.com
Regulatory Overview
Regulation
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Eu Mdd
2
Eu Mdr
2
Classification
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Eu Md Class 1
4
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Expired / Withdrawn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) | CE 689414 | BSI Group The Netherlands B.V. | Oct 08, 2023 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| EpiFaith CV | EU MDR | Eu Md Class 1 | On Market | 0 |
| EpiFaith Syringe | EU MDR | Eu Md Class 1 | On Market | 0 |
| EpiFaith Syringe | EU MDD | Eu Md Class 1 | On Market | 1 |
| EpiFaith Syringe | EU MDD | Eu Md Class 1 | On Market | 1 |