EU Manufacturer
🇮🇳 India
Active
nice Neotech Medical Systems Pvt. Ltd.,
SRN: IN-MF-000010243
·
No. 85, Krishna Industrial Estate, Mettukuppam, Vanagaram, 600095 Chennai, India
Basic UDI-DIs
27
Total Devices
35
On Market
28
Off Market
7
Certificates
4
Valid
0
Expiring < 6mo
0
Countries
1
Basic Information
- Address
- No. 85, Krishna Industrial Estate, Mettukuppam, Vanagaram, 600095 Chennai, India
- [email protected]
- Phone
- +91 9551896959
- Website
- www.niceneotech.com
Regulatory Overview
Regulation
Loading...
Eu Mdd
15
Eu Mdr
12
Classification
Loading...
Eu Md Class 2b
19
Eu Md Class 2a
7
Eu Md Class 1
1
Device Types
Loading...
Certificate Health
Total
4
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
4
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 1434-MDD-300/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 1434-MDD-300/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 1434-MDD-300/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 1434-MDD-072/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2024 |
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
🇹🇷 Türkiye
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| iSmart | EU MDR | Eu Md Class 2a | Not EU | 0 |
| AIR/OXYGEN MASKS | EU MDR | Eu Md Class 2a | On Market | 0 |
| BC 510 BC 555 BC 525 BC 530 BC 570 BC 575 BC 515 BC 535 BC 520 BC 540 BC 545 BC 550 BC 580 BC 585 BC 630 BC 610 BC 615 BC 620 BC 625 BC 635 BC 640 BC 645 BC 650 BC 710 BC 715 BC 720 BC 725 BC 730 BC 735 BC 740 BC 745 50-05-154 50-05-150 | EU MDR | Eu Md Class 2a | On Market | 0 |
| Bili Flex | EU MDR | Eu Md Class 2a | On Market | 0 |
| HORN PUFF | EU MDD | Eu Md Class 2b | On Market | 1 |
| Horn puff | EU MDR | Eu Md Class 2b | On Market | 0 |
| MARS | EU MDR | Eu Md Class 2a | On Market | 0 |
| NEONATOLOGY AND PEDIATRICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES - OTHER | EU MDD | Eu Md Class 1 | On Market | 0 |
| Operah | EU MDR | Eu Md Class 2b | On Market | 0 |
| Operah | EU MDR | Eu Md Class 2b | On Market | 0 |
| Operah | EU MDR | Eu Md Class 2b | On Market | 0 |
| Operah | EU MDD | Eu Md Class 2b | On Market | 1 |
| Operah | EU MDD | Eu Md Class 2b | On Market | 1 |
| Operah | EU MDD | Eu Md Class 2b | On Market | 1 |
| Operah | EU MDD | Eu Md Class 2b | On Market | 1 |
| Operah | EU MDD | Eu Md Class 2b | On Market | 1 |
| Operah Plus | EU MDD | Eu Md Class 2b | On Market | 1 |
| Operah Plus | EU MDD | Eu Md Class 2b | On Market | 1 |
| Operah Plus | EU MDD | Eu Md Class 2b | On Market | 1 |
| Operah plus | EU MDR | Eu Md Class 2b | On Market | 0 |
| Orchid | EU MDR | Eu Md Class 2b | On Market | 0 |
| Orchid | EU MDD | Eu Md Class 2b | On Market | 1 |
| OxyM | EU MDR | Eu Md Class 2b | Not EU | 0 |
| OxyM | EU MDR | Eu Md Class 2b | Not EU | 0 |
| OxyPAP | EU MDR | Eu Md Class 2b | Not EU | 0 |
| OxyPAP | EU MDR | Eu Md Class 2b | Not EU | 0 |
| OxyPAP | EU MDR | Eu Md Class 2b | Not EU | 0 |
| SAPPHIRE | EU MDD | Eu Md Class 2a | On Market | 1 |
| SEEFAR | EU MDD | Eu Md Class 2a | On Market | 1 |
| Sapphire | EU MDR | Eu Md Class 2a | On Market | 0 |
| Seefar | EU MDR | Eu Md Class 2a | On Market | 0 |
| Wallaby | EU MDR | Eu Md Class 2b | On Market | 0 |
| Wallaby | EU MDD | Eu Md Class 2b | On Market | 1 |
| Wallaby | EU MDD | Eu Md Class 2b | On Market | 1 |
| iSmart | EU MDR | Eu Md Class 2a | Not EU | 0 |