Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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Last updated

17.07.2026 07:02

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Active filter:Manufacturer SRN:IN-MF-000010243

25 device results listed.

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Sapphire

Class IIaNot specifiedOn the marketActive device

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989006
Basic UDI-DI: 08908003989SapphireZE
Reference: nice 4000 LED
EMDN: -
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: Türkiye
Authorised representative: Amstermed B.V.
Last updated: 12.07.2026 09:17

Manufacturer products Authorised representative products Authorised representative actors View details

Seefar

Class IIaNot specifiedOn the marketActive device

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989013
Basic UDI-DI: 08908003989SapphireZE
Reference: nice 4000 SPOT
EMDN: -
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: -
Authorised representative: Amstermed B.V.
Last updated: 12.07.2026 09:17

Manufacturer products Authorised representative products Authorised representative actors View details

Operah plus

Class IIbNot specifiedOn the marketActive deviceMeasuring function

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989075
Basic UDI-DI: 08908003989OperahplusTW
Reference: nice 5000 RP
EMDN: -
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
First on market country: Türkiye
Authorised representative: Amstermed B.V.
Last updated: 12.07.2026 09:17

Manufacturer products Authorised representative products Authorised representative actors View details

Wallaby

Class IIbNot specifiedOn the marketActive deviceMeasuring function

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989112
Basic UDI-DI: 08908003989WallabyY5
Reference: nice 3010
EMDN: -
EMDN description: FIXED NEONATAL INCUBATORS
First on market country: Türkiye
Authorised representative: Amstermed B.V.
Last updated: 12.07.2026 09:17

Manufacturer products Authorised representative products Authorised representative actors View details

Orchid

Class IIbNot specifiedOn the marketActive deviceMeasuring function

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989136
Basic UDI-DI: 08908003989Orchid77
Reference: nice 3000
EMDN: -
EMDN description: MOBILE NEONATAL INCUBATORS
First on market country: Türkiye
Authorised representative: Amstermed B.V.
Last updated: 12.07.2026 09:17

Manufacturer products Authorised representative products Authorised representative actors View details

Operah

Class IIbNot specifiedOn the marketActive deviceMeasuring function

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989198
Basic UDI-DI: 08908003989Operah7Z
Reference: nice 2007 S
EMDN: -
EMDN description: NEONATAL RADIANT WARMERS
First on market country: Türkiye
Authorised representative: Amstermed B.V.
Last updated: 12.07.2026 09:17

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Horn puff

Class IIbNot specifiedOn the marketActive device

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989242
Basic UDI-DI: 08908003989Hornpuff54
Reference: nice 5020
EMDN: -
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
First on market country: Türkiye
Authorised representative: Amstermed B.V.
Last updated: 12.07.2026 09:17

Manufacturer products Authorised representative products Authorised representative actors View details

Operah

Class IIbNot specifiedOn the marketActive deviceMeasuring function

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989259
Basic UDI-DI: 08908003989Operah7Z
Reference: nice 2010 BC
EMDN: -
EMDN description: NEONATAL RADIANT WARMERS
First on market country: -
Authorised representative: Amstermed B.V.
Last updated: 12.07.2026 09:17

Manufacturer products Authorised representative products Authorised representative actors View details

Operah

Class IIbNot specifiedOn the marketActive deviceMeasuring function

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989273
Basic UDI-DI: 08908003989Operah7Z
Reference: nice 2010
EMDN: -
EMDN description: NEONATAL RADIANT WARMERS
First on market country: -
Authorised representative: Amstermed B.V.
Last updated: 12.07.2026 09:17

Manufacturer products Authorised representative products Authorised representative actors View details

08908003989334

nice 6000

Class IMDDOn the market

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989334
Basic UDI-DI: B-08908003989334
Reference: nice 6000
EMDN: V028099
EMDN description: NEONATOLOGY AND PEDIATRICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES - OTHER
First on market country: France
Authorised representative: Amstermed B.V.
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Operah

nice 2010 B

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989266
Basic UDI-DI: B-08908003989266
Reference: nice 2010 B
EMDN: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
First on market country: Türkiye
Authorised representative: Amstermed B.V.
Last updated: 10.07.2026 21:26

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Wallaby

nice 3010 H

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989105
Basic UDI-DI: B-08908003989105
Reference: nice 3010 H
EMDN: Z1208040301
EMDN description: FIXED NEONATAL INCUBATORS
First on market country: Türkiye
Authorised representative: Amstermed B.V.
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Operah

nice 5000

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989099
Basic UDI-DI: B-08908003989099
Reference: nice 5000
EMDN: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
First on market country: Türkiye
Authorised representative: Amstermed B.V.
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Operah Plus

nice 5000 P

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989082
Basic UDI-DI: B-08908003989082
Reference: nice 5000 P
EMDN: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: Türkiye
Authorised representative: Amstermed B.V.
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Operah Plus

nice 5000 R

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989068
Basic UDI-DI: B-08908003989068
Reference: nice 5000 R
EMDN: R9099
EMDN description: RESPIRATORY AND ANAESTHESIA DEVICES - OTHER
First on market country: Türkiye
Authorised representative: Amstermed B.V.
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

OxyM

nice 5005, nice 5010

Class IIbMDR 2017/745Not intended for EU marketActive device

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989228
Basic UDI-DI: 8908003989nice5010L3
Reference: nice 5005
EMDN: V0903
EMDN description: CLINICAL/THERAPEUTIC APPLICATIONS GAS MIXTURES
First on market country: -
Authorised representative: Amstermed B.V.
Last updated: 03.07.2026 22:05

Manufacturer products Authorised representative products Authorised representative actors View details

iSmart

nice 8050, nice 8010

Class IIaMDR 2017/745Not intended for EU marketActive deviceMeasuring function

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989204
Basic UDI-DI: 8908003989nice8050M4
Reference: nice 8050
EMDN: R060201
EMDN description: ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,
First on market country: -
Authorised representative: Amstermed B.V.
Last updated: 03.07.2026 22:05

Manufacturer products Authorised representative products Authorised representative actors View details

OxyPAP

nice 5060, nice 5060 S, nice 5060 F

Class IIbMDR 2017/745Not intended for EU marketActive deviceMeasuring function

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989037
Basic UDI-DI: 8908003989nice5060LJ
Reference: nice 5060
EMDN: R060202
EMDN description: OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS
First on market country: -
Authorised representative: Amstermed B.V.
Last updated: 03.07.2026 22:05

Manufacturer products Authorised representative products Authorised representative actors View details

08908003989754

Nasal cannula, Nasal prongs, Nasal mask, Nasal T bar prongs, Resuscitation face mask and Flow tube

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989754
Basic UDI-DI: 08908003989PI6P
Reference: Nasal cannula, Nasal prongs ,Nasal mask , Nasal T bar prongs ,Resuscitation face mask and Flow tube
EMDN: R03010201
EMDN description: AIR/OXYGEN MASKS
First on market country: Türkiye
Authorised representative: Amstermed B.V.
Last updated: 01.07.2026 11:08

Manufacturer products Authorised representative products Authorised representative actors View details

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Infant/Neonatal, Adult, Pediatric, T-piece Resuscitator

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989495
Basic UDI-DI: 08908003989BC4Z
Reference: BC
EMDN: R02010101
EMDN description: BREATHING CIRCUITS, W/O WATER TRAP
First on market country: Türkiye
Authorised representative: Amstermed B.V.
Last updated: 01.07.2026 11:08

Manufacturer products Authorised representative products Authorised representative actors View details