Notified Body
NB 1023
🇨🇿 Czechia
INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390
trida Tomase Bati 299, Louky, 76302 ZLIN, Czechia
View on EUDAMED
Updated Dec 20, 2023
Certificates
16
Valid
7
Expiring < 6mo
0
Expired
7
Basic UDI-DIs
135
Devices
135
Manufacturers
13
Cert. Types
5
Basic Information
- Address
- trida Tomase Bati 299, Louky, 76302 ZLIN, Czechia
- [email protected]
- Phone
- +420-572 779 912
- Website
- www.itczlin.cz
Regulatory Overview
Regulation
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Eu Mdd
131
Eu Ivdd
4
Classification
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Eu Md Class 3
112
Eu Md Class 2b
19
Eu Ivd Annex 2 List A
4
Device Types
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Certificate Health
Total
16
Valid
7
Expiring < 6mo
0
Expired / Withdrawn
7
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 190004 QS/NB | ICZ.HEA a.s. | Jan 16, 2024 | |||
| MDD Annex II (excluding section 4) | 170222 QS/NB | Spatz FGIA Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 200234 QS/NB | AKAS MEDICAL EQUIPMENT | May 27, 2024 | |||
| MDD Annex II (excluding section 4) | 200234QS/NB | AKAS MEDICAL EQUIPMENT | May 27, 2024 | |||
| MDD Annex II (excluding section 4) | 21 0212 QS/NB | M.I.Tech Co., Ltd | May 27, 2024 | |||
| IVDD Annex IV (excluding sections 4, 6) | No. 11 0497 QS/NB | Abon Biopharm(Hangzhou) Co., Ltd | May 26, 2025 | |||
| IVDD Annex IV Section 4 | No. 11 0498 CN/NB | Abon Biopharm(Hangzhou) Co., Ltd | May 26, 2025 | |||
| MDD Annex II (excluding section 4) | 170030QS/NB | Hangzhou Singclean Medical Products Co., Ltd. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 170031CN/NB | Hangzhou Singclean Medical Products Co., Ltd. | Dec 31, 2027 | |||
| MDR QMS | 23 0493 QR/NB | Flídr medical s.r.o. | MDR | Oct 2023 | Oct 31, 2028 | Issued |
| MDR QMS | 23 0517 QR/NB | GAMA GROUP a.s. | MDR | Nov 2023 | Nov 09, 2028 | Issued |
| MDR QMS | 24 0145 QR/NB | BIOSTER, a.s. | MDR | Apr 2024 | Apr 28, 2029 | Issued |
| MDR QMS | 24 0237 QR/NB | VINAMET CZ s.r.o. | MDR | Jun 2024 | Jun 25, 2029 | Issued |
| MDR QMS | 24 0234 QR/NB | BATIST Medical Productions s.r.o. | MDR | Jun 2024 | Jun 25, 2029 | Issued |
| MDR QMS | 24 0263 QR/NB | KARDI AI Technologies s.r.o. | MDR | Jul 2024 | Jul 28, 2029 | Suspended |
| MDR QMS | 24 0477 QR/NB | COMPEX, spol. s r.o. | MDR | Nov 2024 | Nov 27, 2029 | Issued |
Manufacturer Portfolio
| Manufacturer | Certificates | |||
|---|---|---|---|---|
| Hangzhou Singclean Medical Products Co., Ltd. | 🇨🇳 China | 2 | 0 | 0 |
| Abon Biopharm(Hangzhou) Co., Ltd | 🇨🇳 China | 2 | 0 | 0 |
| AKAS MEDICAL EQUIPMENT | 🇮🇳 India | 2 | 0 | 0 |
| COMPEX, spol. s r.o. | 🇨🇿 Czechia | 1 | 1 | 0 |
| KARDI AI Technologies s.r.o. | 🇨🇿 Czechia | 1 | 1 | 0 |
| VINAMET CZ s.r.o. | 🇨🇿 Czechia | 1 | 1 | 0 |
| BATIST Medical Productions s.r.o. | 🇨🇿 Czechia | 1 | 1 | 0 |
| BIOSTER, a.s. | 🇨🇿 Czechia | 1 | 1 | 0 |
| GAMA GROUP a.s. | 🇨🇿 Czechia | 1 | 1 | 0 |
| Flídr medical s.r.o. | 🇨🇿 Czechia | 1 | 1 | 0 |
| M.I.Tech Co., Ltd | 🇰🇷 South Korea | 1 | 0 | 0 |
| Spatz FGIA Inc. | 🇺🇸 United States | 1 | 0 | 0 |
| ICZ.HEA a.s. | 🇨🇿 Czechia | 1 | 0 | 0 |