EU Manufacturer
๐จ๐ณ China
Active
Orantech Inc.
SRN: CN-MF-000013859
ยท
GongMing, 518106 Shenzhen, China
Basic UDI-DIs
660
Total Devices
2213
On Market
2213
Off Market
0
Certificates
8
Valid
0
Expiring < 6mo
0
Countries
10
Basic Information
- Address
- GongMing, 518106 Shenzhen, China
- [email protected]
- Phone
- +86 19925480758
- Website
- www.orantech.com
Regulatory Overview
Regulation
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Eu Mdd
645
Eu Mdr
15
Classification
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Eu Md Class 2b
458
Eu Md Class 2a
187
Eu Md Class 1
15
Device Types
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Certificate Health
Total
8
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
5
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | G1 098084 0003 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | G1 098084 0003 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | G1 098084 000 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | ๏ผG1 098084 0003 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | G1 098084 0003 Rev. 01 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CL 098084 0005 | TรV SรD Product Service GmbH | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | CL 098084 0005 | TรV SรD Product Service GmbH | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | CL 098084 0005 | TรV SรD Product Service GmbH | Dec 31, 2028 |
Market Presence
Devices from this manufacturer are available in 10 countries across Europe.
๐ฆ๐น Austria
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ฌ๐ท Greece
๐ซ๐ท France
๐ญ๐บ Hungary
๐ฑ๐บ Luxembourg
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ท๐ด Romania
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| SpO2 Sensors | EU MDD | Eu Md Class 2b | On Market | 1 |
| SpO2 Sensors | EU MDD | Eu Md Class 2b | On Market | 1 |
| SpO2 Sensors | EU MDD | Eu Md Class 2b | On Market | 1 |
| SpO2 Sensors | EU MDD | Eu Md Class 2b | On Market | 1 |
| Bandage | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bandage | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bandage | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bandage | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bandage | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bandage | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bandage | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bandage | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bandage | EU MDR | Eu Md Class 1 | On Market | 0 |
| Cardiac output cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| Cardiac output cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| Cardiac output cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| Cardiac output cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| DECG Legplate Adapter Cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| DECG Legplate Adapter Cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| DECG Legplate Adapter Cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| DECG Legplate Adapter Cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| DECG Legplate Adapter Cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| DECG Legplate Adapter Cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| DECG Legplate Adapter Cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| DECG Legplate Adapter Cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| DECG Legplate Adapter Cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| DECG Legplate Adapter Cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| DECG Legplate Adapter Cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| DECG Legplate Adapter Cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| DECG Legplate Adapter Cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| DECG Legplate Adapter Cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| DECG Legplate Adapter Cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| DECG Legplate Adapter Cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| DECG Legplate Adapter Cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| DECG Legplate Adapter Cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| DECG Legplate Adapter Cables | EU MDR | Eu Md Class 1 | On Market | 0 |
| DRAIN, TEE | EU MDR | Eu Md Class 1 | On Market | 0 |
| DRAIN, TEE | EU MDR | Eu Md Class 1 | On Market | 0 |
| DRAIN, TEE | EU MDR | Eu Md Class 1 | On Market | 0 |
| DRAIN, TEE | EU MDR | Eu Md Class 1 | On Market | 0 |
| Disposable Temperature Probe | EU MDD | Eu Md Class 2b | On Market | 2 |
| ECG Leaderwires | EU MDR | Eu Md Class 1 | On Market | 0 |
| ECG Leadwires and Trunk Cable | EU MDR | Eu Md Class 1 | On Market | 0 |
| ECG Leadwires and Trunk Cable | EU MDR | Eu Md Class 1 | On Market | 0 |
| ECG Leadwires and Trunk Cable | EU MDR | Eu Md Class 1 | On Market | 0 |
| ECG Leadwires and Trunk Cable | EU MDR | Eu Md Class 1 | On Market | 0 |
| ECG Leadwires and Trunk Cable | EU MDR | Eu Md Class 1 | On Market | 0 |
| ECG Leadwires and Trunk Cable | EU MDR | Eu Md Class 1 | On Market | 0 |
| ECG Leadwires and Trunk Cable | EU MDR | Eu Md Class 1 | On Market | 0 |
| ECG Leadwires and Trunk Cable | EU MDR | Eu Md Class 1 | On Market | 0 |