EU Manufacturer
๐ฏ๐ต Japan
Otsuka Electronics Co., Ltd.
SRN: JP-MF-000001943
ยท
3-26-3, Shodai-Tajika, Hirakata-shi,, 573-1132 Osaka, Japan
Basic UDI-DIs
6
Total Devices
6
On Market
6
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
9
Basic Information
- Address
- 3-26-3, Shodai-Tajika, Hirakata-shi,, 573-1132 Osaka, Japan
- [email protected]
- Phone
- +81 748 63 5454
- Website
- https://www.otsukael.jp/
Regulatory Overview
Regulation
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Eu Ivdr
4
Eu Mdd
1
Eu Mdr
1
Classification
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Eu Ivd Class A
3
Eu Md Class 1
1
Eu Md Class 2b
1
Eu Ivd Class B
1
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Expired / Withdrawn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) | G1 028492 0050 | TรV SรD Product Service GmbH | Oct 22, 2023 |
Market Presence
Devices from this manufacturer are available in 9 countries across Europe.
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ณ๐ด Norway
๐ต๐น Portugal
๐ธ๐ช Sweden
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| AA01 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Adamonitor SC | EU MDD | Eu Md Class 2b | On Market | 1 |
| Adastand ODT-SC001 | EU MDR | Eu Md Class 1 | On Market | 0 |
| NS-Prime | EU IVDR | Eu Ivd Class A | On Market | 0 |
| POConePlus Infrared Spectrophotometer | EU IVDR | Eu Ivd Class B | On Market | 0 |
| POConePlus-AS10 | EU IVDR | Eu Ivd Class A | On Market | 0 |