EU Manufacturer
๐ฏ๐ต Japan
Active
OMRON Healthcare Co., Ltd.
SRN: JP-MF-000007213
ยท
Kunotsubo 53, 617-0002 Kyoto, Japan
Basic UDI-DIs
171
Total Devices
171
On Market
168
Off Market
3
Certificates
0
Valid
0
Expiring < 6mo
0
Countries
30
Basic Information
- Address
- Kunotsubo 53, 617-0002 Kyoto, Japan
- [email protected]
Regulatory Overview
Regulation
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Eu Mdr
171
Classification
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Eu Md Class 2a
115
Eu Md Class 1
56
Device Types
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Certificate Health
No certificates registered for this manufacturer.
Market Presence
Devices from this manufacturer are available in 30 countries across Europe.
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
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 | ||||
|---|---|---|---|---|
| AC-ADAPTER-E1600 (HXA-AC-1300E) | EU MDR | Eu Md Class 1 | On Market | 0 |
| AC-ADAPTER-UK1600 (HEM-AC-UK1040) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Adapter (U17-13P2-E) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Adult Mask (NEB-MSLP-E) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Adult Mask(SEBS) (NEB-MSLS-E) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Air Filter set (NEB-AFS-78E) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Air Tube (NEB-TP-82E) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Air Tube (NEB-TP-L10E) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Air Tube (NEB-TP-L20E) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Air Tube (NEB-TSC-L10E) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Air filter (U17-4P2-E) | EU MDR | Eu Md Class 2a | On Market | 0 |
| BF212 (HBF-212-EW) | EU MDR | Eu Md Class 1 | On Market | 0 |
| BF214 (HBF-214-EBW) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Body Comp Monitor BF511 Blue (HBF-511B-E) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Body Comp Monitor BF511 Turq (HBF-511T-E) | EU MDR | Eu Md Class 1 | On Market | 0 |
| C30-2-UK (C30-UK-AC) | EU MDR | Eu Md Class 1 | On Market | 0 |
| C30-E-AC (C30-2-E) | EU MDR | Eu Md Class 1 | On Market | 0 |
| CL (HEM-CL24-RU) | EU MDR | Eu Md Class 1 | Not EU | 0 |
| CM (HEM-CR24-RU) | EU MDR | Eu Md Class 1 | On Market | 0 |
| CM2 Medium Cuff (HEM-CR24-E) | EU MDR | Eu Md Class 1 | On Market | 0 |
| COLD NEBULISATION SYSTEMS | EU MDR | Eu Md Class 2a | On Market | 0 |
| COLD NEBULISATION SYSTEMS | EU MDR | Eu Md Class 2a | On Market | 0 |
| COMP AIR Basic (NE-C803-E) | EU MDR | Eu Md Class 2a | On Market | 0 |
| COMP AIR Basic (NE-C803-UK) | EU MDR | Eu Md Class 2a | On Market | 0 |
| CS2 Small Cuff (HEM-CS24-E) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Child Mask (NEB-MSMP-E) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Child Mask(SEBS)set (NEB-MSSS-E) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Comp A.I.R. Pro NE-C900 (NE-C900-E) | EU MDR | Eu Md Class 2a | On Market | 0 |
| E3 Intense (HV-F021-ESL) | EU MDR | Eu Md Class 2a | On Market | 0 |
| E3 Intense (HV-F021-EW) | EU MDR | Eu Md Class 2a | On Market | 0 |
| EVOLV (HEM-7600T-E) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Easy Cuff HEM-RML31 (HEM-RML31-E) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Eco Temp Basic (MC-246-E4) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Flex Temp Smart (MC-343F-E4) | EU MDR | Eu Md Class 2a | On Market | 0 |
| GS CUFF L (HXA-GCUFF-LLB) | EU MDR | Eu Md Class 1 | On Market | 0 |
| GS CUFF M (HXA-GCUFF-MLB) | EU MDR | Eu Md Class 1 | On Market | 0 |
| GS CUFF S (HXA-GCUFF-SLB) | EU MDR | Eu Md Class 1 | On Market | 0 |
| GS CUFF SS (HXA-GCUFF-SSLB) | EU MDR | Eu Md Class 1 | On Market | 0 |
| GS CUFF XL (HXA-GCUFF-XLLB) | EU MDR | Eu Md Class 1 | On Market | 0 |
| GS CUFF2 L (HXA-GCFL-PBE) | EU MDR | Eu Md Class 1 | On Market | 0 |
| GS CUFF2 L (HXA-GCFL-PCE) | EU MDR | Eu Md Class 1 | On Market | 0 |
| GS CUFF2 M (HXA-GCFM-PBE) | EU MDR | Eu Md Class 1 | On Market | 0 |
| GS CUFF2 M (HXA-GCFM-PCE) | EU MDR | Eu Md Class 1 | On Market | 0 |
| GS CUFF2 S (HXA-GCFS-PBE) | EU MDR | Eu Md Class 1 | On Market | 0 |
| GS CUFF2 S (HXA-GCFS-PCE) | EU MDR | Eu Md Class 1 | On Market | 0 |
| GS CUFF2 SS (HXA-GCFSS-PBE) | EU MDR | Eu Md Class 1 | On Market | 0 |
| GS CUFF2 SS (HXA-GCFSS-PCE) | EU MDR | Eu Md Class 1 | On Market | 0 |
| GS CUFF2 XL (HXA-GCFXL-PBE) | EU MDR | Eu Md Class 1 | On Market | 0 |
| GS CUFF2 XL (HXA-GCFXL-PCE) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Gentle Temp 520 (MC-520-E) | EU MDR | Eu Md Class 2a | On Market | 0 |