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nice Neotech Medical Systems Pvt. Ltd.,

India·IN-MF-000010243

Last updated September 18, 2026

About

Neonatal Intensive Care Equipment from Niceneotech outstand in quality standards which includes neonatal care equipments, respiratory care equipments, disposable accessories , reusable accessories and so on.

From the manufacturer's own website. Source

What nice Neotech Medical Systems Pvt. Ltd., makes

The company manufactures neonatal intensive care equipment, including neonatal and respiratory care devices such as incubators (e.g., Orchid, Operah, Operah Plus), infant observation trolleys, and disposable and reusable accessories (e.g., BC series, HORN PUFF, Sapphire). Additional products include a dedicated infant monitoring system (Wallaby) and a neonatal respiratory support device (MARS).

These devices are classified under EU Medical Device Regulations as Class I, Class IIa, and Class IIb, with relevant entries listed in the EU’s eudamed database. The manufacturer is based in India.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
India
Address
No. 85-86, Krishna Industrial Estate, Mettukuppam, Vanagaram, Chennai, India
Phone
+91 9551896959
PRRC Contact
Balasubramani Gunaseelan
EUDAMED SRN
IN-MF-000010243
FDA FEI Number
—
DUNS Number
—

Catalogue (19)

DeviceModel / ReferenceRegistriesClassStatus
Orchid nice 3000
EUDAMED
Class IIbActive
Operah Plus nice 5000 RP
EUDAMED
Class IIbActive
Infant Observation Trolley nice 6000
EUDAMED
Class IActive
Wallaby nice 3010 H
EUDAMED
Class IIbActive
Mars nice 5001
EUDAMED
Class IIaActive
Operah nice 2010 B
EUDAMED
Class IIbActive
Operah nice 2007 S
EUDAMED
Class IIbActive
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 BC
EUDAMED
Class IIaActive
Wallaby nice 3010
EUDAMED
Class IIbActive
Operah nice 2010 BC
EUDAMED
Class IIbActive
Horn Puff nice 5020
EUDAMED
Class IIbActive
Sapphire nice 4000 LED
EUDAMED
Class IIaActive
Patient Interfaces Nasal cannula, Nasal prongs ,Nasal mask , Nasal T bar prongs ,Resuscitation face mask and Flow tube
EUDAMED
Class IIaActive
OxyM nice 5005
EUDAMED
Class IIbActive
iSmart nice 8050
EUDAMED
Class IIaActive
Seefar nice 4000 SPOT
EUDAMED
Class IIaActive
Operah Plus nice 5000 P
EUDAMED
Class IIbActive
Operah nice 2010
EUDAMED
Class IIbActive
OxyPAP nice 5060 F
EUDAMED
Class IIbActive

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