Notified Body
NB 2265
🇸🇰 Slovakia
3EC International a.s.
3EC International a.s. Hranicna 18 Bratislava 82105 SLOVAKIA, Bratislava
82105, Slovakia
View on EUDAMED
Updated Oct 3, 2021
Certificates
100
Valid
47
Expiring < 6mo
0
Expired
45
Basic UDI-DIs
166
Devices
218
Manufacturers
42
Cert. Types
7
Basic Information
- Address
- 3EC International a.s. Hranicna 18 Bratislava 82105 SLOVAKIA, Bratislava 82105, Slovakia
- [email protected]
- Phone
- +421 2 58318343
- Website
- www.3ec.sk
Regulatory Overview
Regulation
Loading...
Eu Mdd
159
Eu Mdr
5
Eu Ivdd
2
Classification
Loading...
Eu Md Class 3
125
Eu Md Class 2b
26
Eu Md Class 2a
12
Eu Md Class 1
1
Eu Ivd Annex 2 List A
1
Eu Ivd Self Testing
1
Device Types
Loading...
Certificate Health
Total
100
Valid
47
Expiring < 6mo
0
Expired / Withdrawn
45
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 2021-MDD/QS-054 | MEDICAL TECHNOLOGIES Ltd | May 21, 2021 | |||
| MDD Annex II (excluding section 4) | 2017-MDD/QS-035/B | Hans Biomed Corp. | Jul 23, 2022 | |||
| MDD Annex II Section 4 | 2017-MDD/DE-036/B | Hans Biomed Corp. | Jul 23, 2022 | |||
| MDD Annex II (excluding section 4) | 2017-MDD/QS-035/B | Hans Biomed Corp. | Jul 23, 2022 | |||
| MDD Annex II (excluding section 4) | 2017-MDD/QS-044/C, 2017-MDD/DE-045/C | BNC KOREA, Inc. | Oct 01, 2022 | |||
| MDD Annex II (excluding section 4) | 2018-MDD/QS-013 | Chungwoo Co., Ltd. | Jun 14, 2023 | |||
| MDD Annex II (excluding section 4) | 2018-MDD/QS-032/C | NEXTBIOMEDICAL CO., LTD. | Dec 04, 2023 | |||
| MDD Annex II Section 4 | 2018-MDD/DE-033/C | NEXTBIOMEDICAL CO., LTD. | Dec 04, 2023 | |||
| MDD Annex II (excluding section 4) | 2018-MDD/QS-034C | NEXTBIOMEDICAL CO., LTD. | Dec 04, 2023 | |||
| MDD Annex II (excluding section 4) | 2019-MDD/QS-011/A | IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A. | Jan 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2019-MDD/QS-010/A | IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A. | Jan 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2019-MDD/QS-016 | IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A. | Jan 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2019-MDD/QS-014 | IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A. | Jan 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2019-MDD/QS-015 | IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A. | Jan 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2019-MDD/QS-020/A | Ubiosis | Feb 21, 2024 | |||
| MDD Annex VI | 2019-MDD/QS-032 | TatraMed Software s.r.o. | Apr 24, 2024 | |||
| MDD Annex II (excluding section 4) | 2020-MDD/QS-006 | TatraMed Software s.r.o. | Apr 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2019-MDD/QS-047 | WOLF-Medizintechnik GmbH | May 25, 2024 | |||
| MDD Annex II Section 4 | 2019_MDD/QS-047 | WOLF-Medizintechnik GmbH | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 2021-MDD/QS-021 | Chetan Meditech Pvt. Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2020-MDD/QS-024 | SIA "LINLINE Medical Systems" | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2019-MDD/QS-067/A | Chetan Meditech Pvt. Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2020-MDD/QS-025 | Nuga Medical Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2021-MDD/QS-008 | BrainU Co.,Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2021-MDD/QS-052 | NEXTBIOMEDICAL CO., LTD. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2021-MDD/DE-053 | NEXTBIOMEDICAL CO., LTD. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2020-MDD/QS-082 | IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2020-MDD/QS-085 | IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2020-MDD/QS-083 | IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2020-MDD/QS-084 | IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2019-MDD/QS-053/A | Innovation Imaging Technologies Pvt. Ltd | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2019-MDD/QS-093 | MEDICAL TECHNOLOGY TRANSFER AND SERVICES COMPANY LIMITED | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2019-MDD/QS-092 | MEDICAL TECHNOLOGY TRANSFER AND SERVICES COMPANY LIMITED | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2019-MDD/QS-077 | MEDICAL TECHNOLOGY TRANSFER AND SERVICES COMPANY LIMITED | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2019-MDD/QS-091 | MEDICAL TECHNOLOGY TRANSFER AND SERVICES COMPANY LIMITED | May 26, 2024 | |||
| IVDD Annex IV (excluding sections 4, 6) | No.2020-IVD/QS-008 | CTK Biotech Inc. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2020-MDD/QS-086/A | Elixir Medical Corporation | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2020-MDD/QS-005 | TATRAMED spol. s r.o. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2020-MDD/QS-093 | Chungwoo Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2021-MDD/QS-022 | OR-CZ spol. s r.o. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2021-MDD/QS-023, 2021-MDD/DE-024 | BNC KOREA, Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2020-MDD/QS-037/A | NEXTBIOMEDICAL CO., LTD. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2021-MDD/QS-025 | SJ Global Co., Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2020-MDD/DE-087/A | Elixir Medical Corporation | May 26, 2024 | |||
| IVDD Annex III Section 6 | 2020-IVD/DE-006/A | Assure Tech. (Hangzhou) Co., Ltd. | May 26, 2025 | |||
| MDR QMS | 2022-MDR/QS-001/A | MEDKONSULT medical technology s.r.o. | MDR | Jul 2022 | Mar 21, 2027 | Supplemented |
| MDR QMS | 2022-MDR/QS-002 | HEALTHIUM MEDTECH LIMITED | MDR | Jun 2022 | Jun 02, 2027 | Issued |
| MDR QMS | 2022-MDR/QS-017 | HEALTHIUM MEDTECH LIMITED | MDR | Oct 2022 | Aug 15, 2027 | Amended |
| MDR QMS | 2022-MDR/QS-016 | HEALTHIUM MEDTECH LIMITED | MDR | Oct 2022 | Aug 15, 2027 | Amended |
| MDR QMS | 2022-MDR/QS-015 | HEALTHIUM MEDTECH LIMITED | MDR | Oct 2022 | Aug 15, 2027 | Amended |
| MDR QMS | 2022-MDR/QS-012 | HEALTHIUM MEDTECH LIMITED | MDR | Oct 2022 | Aug 15, 2027 | Amended |
| MDR QMS | 2022-MDR/QS-011 | HEALTHIUM MEDTECH LIMITED | MDR | Oct 2022 | Aug 15, 2027 | Amended |
| MDR QMS | 2022-MDR/QS-010 | HEALTHIUM MEDTECH LIMITED | MDR | Oct 2022 | Aug 15, 2027 | Amended |
| MDR QMS | 2022-MDR/QS-009 | HEALTHIUM MEDTECH LIMITED | MDR | Oct 2022 | Aug 15, 2027 | Amended |
| MDR QMS | 2022-MDR/QS-008 | HEALTHIUM MEDTECH LIMITED | MDR | Oct 2022 | Aug 15, 2027 | Amended |
| MDR QMS | 2022-MDR/QS-007 | HEALTHIUM MEDTECH LIMITED | MDR | Oct 2022 | Aug 15, 2027 | Amended |
| MDR QMS | 2022-MDR/QS-006 | HEALTHIUM MEDTECH LIMITED | MDR | Oct 2022 | Aug 15, 2027 | Amended |
| MDR QMS | 2022-MDR/QS-005 | HEALTHIUM MEDTECH LIMITED | MDR | Oct 2022 | Aug 15, 2027 | Amended |
| MDR QMS | 2022-MDR/QS-018 | HEALTHIUM MEDTECH LIMITED | MDR | Aug 2022 | Aug 15, 2027 | Issued |
| MDR QMS | 2022-MDR/QS-020 | MEDORO s.r.o. | MDR | Sep 2022 | Sep 09, 2027 | Issued |
| MDR QMS | 2022-MDR/QS-021 | FOTONA, proizvodnja optoelektronskih naprav d.o.o. | MDR | Sep 2022 | Sep 21, 2027 | Issued |
| MDR QMS | 2022-MDR/QS-022 | MEDIST, s.r.o. | MDR | Sep 2022 | Sep 27, 2027 | Issued |
| MDR QMS | 2022-MDR/QS-027 | CHIRANA T.Injecta, a.s. | MDR | Sep 2022 | Sep 30, 2027 | Issued |
| MDR QMS | 2022-MDR/QS-026 | CHIRANA T.Injecta, a.s. | MDR | Sep 2022 | Sep 30, 2027 | Issued |
| MDR QMS | 2022-MDR/QS-025 | CHIRANA T.Injecta, a.s. | MDR | Sep 2022 | Sep 30, 2027 | Issued |
| MDR QMS | 2022-MDR/QS-024 | CHIRANA T.Injecta, a.s. | MDR | Sep 2022 | Sep 30, 2027 | Issued |
| MDR QMS | 2022-MDR/QS-028 | Neofyt spol. s r.o. | MDR | Dec 2022 | Dec 09, 2027 | Issued |
| MDD Annex II Section 4 | 2019-MDD/QS-088/A, 2019-MDD/DE-009/A | Dalim Tissen Co., Ltd. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 2019-MDD/QS-006/A, 2019-MDD/DE-007/A | Dalim Tissen Co., Ltd. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 2019-MDD/QS-006/A, 2019-MDD/DE-007/A | Dalim Tissen Co., Ltd. | Dec 31, 2027 | |||
| MDR QMS | 2023-MDR/QS-004 | BNC KOREA, Inc. | MDR | Jan 2023 | Jan 09, 2028 | Issued |
| MDR QMS | 2023-MDR/QS-003 | — | MDR | Jan 2023 | Jan 09, 2028 | Issued |
| MDR QMS | 2023-MDR/QS-002 | — | MDR | Jan 2023 | Jan 09, 2028 | Issued |
| MDR QMS | 2023-MDR/QS-001 | — | MDR | Jan 2023 | Jan 09, 2028 | Issued |
| MDR QMS | 2023-MDR/QS-005 | BEZNOSKA, s.r.o. | MDR | May 2023 | May 12, 2028 | Issued |
| MDR QMS | 2023-MDR/QS-006 | Aireen a.s. | MDR | May 2023 | May 19, 2028 | Issued |
| MDR QMS | 2024-MDR/QS-010 | TatraMed Software s.r.o. | MDR | Mar 2024 | Mar 06, 2029 | Issued |
| MDR QMS | 2024-MDR/QS-022 | Herb-Pharma Corporation s.r.o. | MDR | Apr 2024 | Apr 18, 2029 | Issued |
| MDR QMS | 2024-MDR/QS-027 | H&abyz | MDR | May 2024 | May 06, 2029 | Issued |
| MDR QMS | 2024-MDR/QS-036 | Chetan Meditech Pvt. Ltd. | MDR | Jul 2024 | Jul 01, 2029 | Issued |
| MDR QMS | 2024-MDR/QS-035 | Chetan Meditech Pvt. Ltd. | MDR | Jul 2024 | Jul 01, 2029 | Issued |
| MDR QMS | 202-MDR/QS-034 | Chetan Meditech Pvt. Ltd. | MDR | Jul 2024 | Jul 01, 2029 | Issued |
| MDR QMS | 2024-MDR/QS-032 | Chetan Meditech Pvt. Ltd. | MDR | Jul 2024 | Jul 01, 2029 | Issued |
| MDR QMS | 2024-MDR/QS-033 | Chetan Meditech Pvt. Ltd. | MDR | Jul 2024 | Jul 01, 2029 | Issued |
| MDR QMS | 2024-MDR/QS-031 | Chetan Meditech Pvt. Ltd. | MDR | Jul 2024 | Jul 01, 2029 | Issued |
| MDR QMS | 2024-MDR/QS-046 | MEDICA FILTER spol. s r.o. | MDR | Jul 2024 | Jul 16, 2029 | Issued |
| MDR QMS | 2024-MDR/QS-045 | MEDICA FILTER spol. s r.o. | MDR | Jul 2024 | Jul 16, 2029 | Issued |
| MDR QMS | 2024-MDR/QS-050 | HuBioMed Inc. | MDR | Jul 2024 | Jul 29, 2029 | Issued |
| MDR QMS | 2024-MDR/QS-051 | Pentamaster MediQ Sdn. Bhd. | MDR | Aug 2024 | Aug 07, 2029 | Issued |
| MDR QMS | 2024-MDR/QS-052 | Medical Impact | MDR | Aug 2024 | Aug 28, 2029 | Issued |
| MDR QMS | 2024-MDR/QS-060 | Vortran Medical Technology 1 Inc. | MDR | Nov 2024 | Nov 01, 2029 | Issued |
| MDR QMS | 2024-MDR/QS-061 | Elixir Medical Corporation | MDR | Nov 2024 | Nov 08, 2029 | Issued |
| MDR QMS | 2024-MDR/QS-063 | ZHIVAS LTD | MDR | Nov 2024 | Nov 08, 2029 | Issued |
| MDR QMS | 2024-MDR/QS-062 | ZHIVAS LTD | MDR | Nov 2024 | Nov 08, 2029 | Issued |
| MDR QMS | 2024-MDR/QS-064 | WOLF-Medizintechnik GmbH | MDR | Nov 2024 | Nov 15, 2029 | Issued |
| MDR Technical Documentation | — | Bloomage Biotechnology Corp.,Ltd. | — | |||
| MDR Technical Documentation | 2024-MDR/TD-031 | Chetan Meditech Pvt. Ltd. | — | |||
| MDR Technical Documentation | 2024-MDR/QS-055, 2024-MDR/TD-055 | Dalim Tissen Co., Ltd. | — | |||
| MDR Technical Documentation | 2024-MDR/QS-056, 2024-MDR/TD-056 | Dalim Tissen Co., Ltd. | — | |||
| MDR Technical Documentation | 2022-MDR/TD-023/A | Shin poong Pharm Co.,Ltd. | — |