EU Manufacturer
๐น๐ผ Taiwan
Active
DELBIO INC.
SRN: TW-MF-000003400
ยท
4F.(5F.), NO. 16, TUNGYUAN ROAD, , 320 TAOYUAN CITY, Taiwan
Basic UDI-DIs
7
Total Devices
14
On Market
13
Off Market
1
Certificates
3
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- 4F.(5F.), NO. 16, TUNGYUAN ROAD, , 320 TAOYUAN CITY, Taiwan
- [email protected]
- Phone
- +886-3-3596268
Regulatory Overview
Regulation
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Eu Mdd
5
Eu Ivdr
2
Classification
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Eu Md Class 2a
5
Eu Ivd Class A
2
Device Types
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Certificate Health
Total
3
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
3
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | HD 2339568-1 | TรV Rheinland LGA Products GmbH | Dec 18, 2023 | |||
| MDD Annex II (excluding section 4) | HD2339568-1 | TรV Rheinland LGA Products GmbH | Dec 19, 2023 | |||
| MDD Annex II (excluding section 4) | HD 2339568-1 | TรV Rheinland LGA Products GmbH | Dec 19, 2023 |
Market Presence
Devices from this manufacturer are available in 32 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Aposรกn | EU MDD | Eu Md Class 2a | On Market | 1 |
| DELBIO Automated Nucleic Acid Analysis System | EU IVDR | Eu Ivd Class A | On Market | 0 |
| DELBIO Automated Nucleic Acid Analysis System | EU IVDR | Eu Ivd Class A | On Market | 0 |
| DELBIO GS1 Nucleic Acid Extraction Kit | EU IVDR | Eu Ivd Class A | On Market | 0 |
| DELBIO GS2 Nucleic Acid Extraction Kit | EU IVDR | Eu Ivd Class A | On Market | 0 |
| DELBIO GS2 Nucleic Acid Extraction Kit | EU IVDR | Eu Ivd Class A | On Market | 0 |
| GS Nucleic Acid Extraction Kit | EU IVDR | Eu Ivd Class A | On Market | 0 |
| MiniLab System | EU IVDR | Eu Ivd Class A | On Market | 0 |
| PULSE OXIMETERS | EU MDD | Eu Md Class 2a | Off Market | 1 |
| SPENGLER | EU MDD | Eu Md Class 2a | On Market | 1 |
| SPENGLER | EU MDD | Eu Md Class 2a | On Market | 1 |
| SPENGLER | EU MDD | Eu Md Class 2a | On Market | 1 |
| Vircell GS Nucleic Acid Extraction Kit | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Vircell Molecular Analysis POC System G1 | EU IVDR | Eu Ivd Class A | On Market | 0 |