Notified Body
NB 1304
🇸🇮 Slovenia
SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
Mašera - Spasićeva ulica 10, 1000 LJUBLJANA, Slovenia
View on EUDAMED
Updated Apr 1, 2022
Certificates
48
Valid
20
Expiring < 6mo
0
Expired
28
Basic UDI-DIs
1871
Devices
1871
Manufacturers
29
Cert. Types
4
Basic Information
- Address
- Mašera - Spasićeva ulica 10, 1000 LJUBLJANA, Slovenia
- [email protected]
- Phone
- +386 1 4778 000
- Website
- http://www.siq.si/
Regulatory Overview
Regulation
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Eu Mdd
1871
Classification
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Eu Md Class 2b
1504
Eu Md Class 2a
286
Eu Md Class 1
81
Device Types
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Certificate Health
Total
48
Valid
20
Expiring < 6mo
0
Expired / Withdrawn
28
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex V | 1304 | Medgyn International, Inc | Mar 26, 2024 | |||
| MDD Annex II (excluding section 4) | MDD-072 | adeor medical AG | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | MDD-140 | Eonex d.o.o. | May 26, 2024 | |||
| MDD Annex V | MDD-124 | Medgyn International, Inc | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | MDD-103 | PRIZMA KRAGUJEVAC DOO | May 26, 2024 | |||
| MDD Annex V | MDD-010 | NIVA DOO ŽABALJ | May 26, 2024 | |||
| MDD Annex V | 100 | Medgyn International, Inc | May 26, 2024 | |||
| MDD Annex V | MDD-100 | Medgyn International, Inc | May 26, 2024 | |||
| MDD Annex V | mdd-100 | Medgyn International, Inc | May 26, 2024 | |||
| MDD Annex V | MDD-155 | ARMOR d.o.o. AZANJA | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | MDD-186 | 3F-Fit Fabricando Faber doo | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | MDD-152 | Multi Radiance Medical | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | MD-152 | Multi Radiance Medical | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | MDD-132 | Narcissus doo | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | MDD-099 | Ekliptik razvoj in svetovanje d.o.o. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | MDD-202 | IMP - PIEZOTEHNOLOGIJA DOO BEOGRAD | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | MD-132 | Narcissus doo | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | / | Ekliptik razvoj in svetovanje d.o.o. | May 26, 2024 | |||
| MDD Annex V | MDD-193 | Biolux Technology GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | MDD-134 | Narcissus doo | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | mdd-132 | Narcissus doo | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | Mdd-132 | Narcissus doo | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | NA.02.3018 | Narcissus doo | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | MDD-132 | Narcissus doo | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | NDD-132 | Narcissus doo | May 26, 2024 | |||
| MDD Annex V | 193 | Biolux Technology GmbH | May 26, 2024 | |||
| MDD Annex II Section 4 | MDD-153 | SGM d.o.o. | May 27, 2024 | |||
| MDD Annex II (excluding section 4) | MMM-153 | SGM d.o.o. | May 27, 2024 | |||
| MDR QMS | MDR-001 | Meridian Medical d.o.o. | MDR | Mar 2023 | Mar 22, 2028 | Issued |
| MDR QMS | MDR-003 | SHL Solutions for Healthcare and Life-Sciences GmbH | MDR | Nov 2024 | Sep 26, 2028 | Amended |
| MDR QMS | MDR-002 | Kirchner & Wilhelm GmbH + Co KG | MDR | Sep 2023 | Sep 26, 2028 | Issued |
| MDR QMS | MDR-005 | MESI, development of medical devices, Ltd. | MDR | Dec 2023 | Dec 21, 2028 | Issued |
| MDR QMS | MDR-004 | Biolux Technology GmbH | MDR | Dec 2023 | Dec 21, 2028 | Issued |
| MDR QMS | MDR-006 | Smart Blood Analytics Swiss SA | MDR | Apr 2024 | Dec 26, 2028 | Supplemented |
| MDR QMS | MDR-007 | BrainCapture ApS | MDR | Jan 2024 | Jan 23, 2029 | Issued |
| MDR QMS | MDR-008 | CSD Labs GmbH | MDR | Feb 2024 | Feb 20, 2029 | Issued |
| MDR QMS | MDR-009 | UAB Teltonika Telemedic | MDR | Mar 2024 | Mar 19, 2029 | Issued |
| MDR QMS | MDR -0012 | — | MDR | Jun 2024 | Jun 18, 2029 | Issued |
| MDR QMS | MDR-0013 | — | MDR | Dec 2024 | Jul 23, 2029 | Supplemented |
| MDR QMS | MDR-0014 | Polident d.o.o. Industrija dentalnih proizvodov | MDR | Dec 2024 | Jul 29, 2029 | Supplemented |
| MDR QMS | MDR-0015 | Meridian Medical d.o.o. | MDR | Sep 2024 | Aug 08, 2029 | Supplemented |
| MDR QMS | MDR-0016 | Optotek d.o.o. | MDR | Sep 2024 | Sep 15, 2029 | Issued |
| MDR QMS | MDR-0017 | VitalThings AS | MDR | Oct 2024 | Sep 30, 2029 | Issued |
| MDR QMS | MDR-0019 | newbox medical GmbH | MDR | Oct 2024 | Oct 15, 2029 | Issued |
| MDR QMS | MDR-0018 | adeor medical AG | MDR | Oct 2024 | Oct 15, 2029 | Issued |
| MDR QMS | MDR-0020 | PHARMA PRODUCT DOO | MDR | Oct 2024 | Oct 23, 2029 | Issued |
| MDR QMS | MDR-0021 | Delmont imaging | MDR | Nov 2024 | Nov 07, 2029 | Issued |
| MDR QMS | MDR-0022 | SCHUHFRIED GmbH | MDR | Dec 2024 | Dec 12, 2029 | Issued |