EU Manufacturer
๐จ๐ณ China
Active
Shenzhen Comen Medical Instruments Co.,LTD.
SRN: CN-MF-000002236
ยท
Floor 10, Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to Floor 5 of Building 2, FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-district, Guangming District, Shenzhen, Guangdong, 518106, P.R.China., 518106 Shenzhen, China
Basic UDI-DIs
243
Total Devices
411
On Market
411
Off Market
0
Certificates
8
Valid
0
Expiring < 6mo
0
Countries
9
Basic Information
- Address
- Floor 10, Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to Floor 5 of Building 2, FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-district, Guangming District, Shenzhen, Guangdong, 518106, P.R.China., 518106 Shenzhen, China
- [email protected]
- Phone
- + 86-755-26431236
Regulatory Overview
Regulation
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Eu Mdd
159
Eu Ivdd
64
Eu Mdr
20
Classification
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Eu Md Class 2b
132
Eu Ivd General
64
Eu Md Class 1
27
Eu Md Class 2a
20
Device Types
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Certificate Health
Total
8
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
8
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | CN19/41057 | SGS Belgium NV | Feb 05, 2023 | |||
| MDD Annex II (excluding section 4) | "CN19/41057 " | SGS Belgium NV | Feb 05, 2023 | |||
| MDD Annex II (excluding section 4) | 1639 | SGS Belgium NV | Feb 05, 2023 | |||
| MDD Annex II (excluding section 4) | CN19/41057 | SGS Belgium NV | Feb 05, 2023 | |||
| MDD Annex II (excluding section 4) | FI21/07001 | SGS FIMKO OY | May 23, 2024 | |||
| MDD Annex II (excluding section 4) | Fl21/07001 | SGS FIMKO OY | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | HD 60150327 0001 | TรV Rheinland LGA Products GmbH | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 17058047008 | TรV Rheinland LGA Products GmbH | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 9 countries across Europe.
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐ฉ๐ช Germany
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฒ๐น Malta
๐ต๐ฑ Poland
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Anaesthesia Machine | EU MDD | Eu Md Class 2b | On Market | 1 |
| Anaesthesia Machine | EU MDD | Eu Md Class 2b | On Market | 1 |
| Anaesthesia Machine | EU MDD | Eu Md Class 2b | On Market | 1 |
| Anaesthesia Machine | EU MDD | Eu Md Class 2b | On Market | 1 |
| Anaesthesia Machine | EU MDD | Eu Md Class 2b | On Market | 1 |
| Anaesthesia Machine | EU MDD | Eu Md Class 2b | On Market | 1 |
| Anaesthesia Machine | EU MDD | Eu Md Class 2b | On Market | 1 |
| Anaesthesia Machine | EU MDD | Eu Md Class 2b | On Market | 1 |
| Anaesthesia Machine | EU MDD | Eu Md Class 2b | On Market | 1 |
| Anaesthesia Machine | EU MDD | Eu Md Class 2b | On Market | 1 |
| Anaesthetic Gas Scavenging System | EU MDR | Eu Md Class 2a | On Market | 0 |
| Anaesthetic Gas Scavenging System | EU MDR | Eu Md Class 2a | On Market | 0 |
| Anaesthetic Gas Scavenging System | EU MDD | Eu Md Class 2a | On Market | 1 |
| Automatic Hematology Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| Automatic Hematology Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| Automatic Hematology Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| Automatic Hematology Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| Automatic Hematology Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| Automatic Hematology Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| Automatic Hematology Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| Automatic Hematology Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| Automatic Hematology Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| Automatic Hematology Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| Automatic Hematology Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| Automatic Hematology Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| Automatic Hematology Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| Automatic Hematology Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| Automatic Hematology Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| Automatic Hematology Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| Automatic Hematology Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| Automatic Hematology Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| Automatic Hematology Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| Automatic Hematology Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| Automatic Hematology Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| C-Reactive Protein Calibrator | EU IVDD | Eu Ivd General | On Market | 0 |
| C-Reactive Protein Control | EU IVDD | Eu Ivd General | On Market | 0 |
| CPR Sensor | EU MDR | Eu Md Class 2a | On Market | 0 |
| Catheter-positioning guiding system | EU MDR | Eu Md Class 2b | On Market | 0 |
| Catheter-positioning guiding system | EU MDR | Eu Md Class 2b | On Market | 0 |
| Catheter-positioning guiding system | EU MDD | Eu Md Class 2b | On Market | 1 |
| Catheter-positioning guiding system | EU MDD | Eu Md Class 2b | On Market | 1 |
| Ceiling Pendant | EU MDR | Eu Md Class 2b | On Market | 0 |
| Ceiling Pendant | EU MDR | Eu Md Class 2b | On Market | 0 |
| Ceiling Pendant | EU MDR | Eu Md Class 2b | On Market | 0 |
| Ceiling Pendant | EU MDR | Eu Md Class 2b | On Market | 0 |
| Ceiling Pendant | EU MDR | Eu Md Class 2b | On Market | 0 |
| Ceiling Pendant | EU MDR | Eu Md Class 2b | On Market | 0 |
| Ceiling Pendant | EU MDD | Eu Md Class 2b | On Market | 1 |
| Ceiling Pendant | EU MDD | Eu Md Class 2b | On Market | 1 |
| Ceiling Pendant | EU MDD | Eu Md Class 2b | On Market | 1 |