EU Manufacturer
π―π΅ Japan
Active
HAKKO CO., LTD.
SRN: JP-MF-000010711
Β·
1490 O-aza Isobe, 389-0806 Chikuma-Shi, Nagano, Japan
Basic UDI-DIs
2
Total Devices
2
On Market
2
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
1
Basic Information
- Address
- 1490 O-aza Isobe, 389-0806 Chikuma-Shi, Nagano, Japan
- [email protected]
- Website
- www.hakko-medical.com
Regulatory Overview
Regulation
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Eu Mdd
2
Classification
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Eu Md Class 2a
2
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Expired / Withdrawn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) | CE 549032 | BSI Group The Netherlands B.V. | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
π©πͺ Germany
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE | EU MDD | Eu Md Class 2a | On Market | 1 |
| SHEARING BIOPSY NEEDLES | EU MDD | Eu Md Class 2a | On Market | 1 |