EU Manufacturer
🇸🇪 Sweden
Active
Bioglan AB
SRN: SE-MF-000001889
·
Borrgatan 31, 21124 Malmö, Sweden
Basic UDI-DIs
3
Total Devices
3
On Market
3
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
4
Basic Information
- Address
- Borrgatan 31, 21124 Malmö, Sweden
- [email protected]
- Phone
- +46 40 28 75 00
- Website
- www.bioglan.se
Regulatory Overview
Regulation
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Eu Mdd
2
Eu Mdr
1
Classification
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Eu Md Class 1
2
Eu Md Class 3
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Expired / Withdrawn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 Section 4 | 595697 | BSI Group The Netherlands B.V. | May 25, 2024 |
Market Presence
Devices from this manufacturer are available in 4 countries across Europe.
🇪🇸 Spain
🇮🇹 Italy
🇵🇹 Portugal
🇸🇪 Sweden
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Molucide | EU MDD | Eu Md Class 1 | On Market | 0 |
| OTOSPRAY | EU MDR | Eu Md Class 1 | On Market | 0 |
| Zalve wound healing cream | EU MDD | Eu Md Class 3 | On Market | 1 |