EU Manufacturer
πΉπΌ Taiwan
Active
MEDIHIGHTEC MEDICAL CO., LTD.
SRN: TW-MF-000023883
Β·
18F.- 2, No. 81, Sec. 1, Xintai 5th Road,, 22101 New Taipei City, Taiwan
Basic UDI-DIs
2
Total Devices
2
On Market
2
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
4
Basic Information
- Address
- 18F.- 2, No. 81, Sec. 1, Xintai 5th Road,, 22101 New Taipei City, Taiwan
- [email protected]
- Website
- www.medihightec.com
Regulatory Overview
Regulation
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Eu Mdd
2
Classification
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Eu Md Class 2a
2
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Expired / Withdrawn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) | 10022-2017-CE-RGC-NA-PS | DNV Product Assurance AS | May 14, 2023 |
Market Presence
Devices from this manufacturer are available in 4 countries across Europe.
π©πͺ Germany
πͺπΈ Spain
π΅π± Poland
π·π΄ Romania
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES | EU MDD | Eu Md Class 2a | On Market | 1 |
| TENS/EMS combo | EU MDD | Eu Md Class 2a | On Market | 1 |