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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05.07.2026 13:56

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Active filter:Manufacturer SRN:IN-MF-000010243

25 device results listed.

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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

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

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

MARS

nice 5001

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989310
Basic UDI-DI: 08908003989MARSYJ
Reference: nice 5001
EMDN: V0903
EMDN description: CLINICAL/THERAPEUTIC APPLICATIONS GAS MIXTURES
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

Horn puff

nice 5020

Class IIbMDR 2017/745On 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: R03020201
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
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

Operah

nice 2010 BC, nice 2010, nice 2007 S

Class IIbMDR 2017/745On 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: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
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

Orchid

nice 3000

Class IIbMDR 2017/745On 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: Z1208040302
EMDN description: MOBILE NEONATAL INCUBATORS
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

Wallaby

nice 3010

Class IIbMDR 2017/745On 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: Z1208040301
EMDN description: FIXED NEONATAL INCUBATORS
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

Operah plus

nice 5000 RP

Class IIbMDR 2017/745On 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: R03020201
EMDN description: MANUALLY OPERATED PULMONARY RESUSCITATORS
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

Sapphire

nice 4000 LED, nice 4000 SPOT

Class IIaMDR 2017/745On 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: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
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

Seefar

Class IIaMDR 2017/745On 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: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: -
Authorised representative: Amstermed B.V.
Last updated: 29.06.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

OxyPAP

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

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989044
Basic UDI-DI: 8908003989nice5060LJ
Reference: nice 5060 S
EMDN: R060202
EMDN description: OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS
First on market country: -
Authorised representative: Amstermed B.V.
Last updated: 29.06.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

OxyPAP

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

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989051
Basic UDI-DI: 8908003989nice5060LJ
Reference: nice 5060 F
EMDN: R060202
EMDN description: OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS
First on market country: -
Authorised representative: Amstermed B.V.
Last updated: 29.06.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

Operah Plus

Class IIbNot specifiedOn the market

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: -
EMDN description: -
First on market country: -
Authorised representative: Amstermed B.V.
Last updated: 29.06.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

Operah Plus

Class IIbNot specifiedOn the market

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: -
EMDN description: -
First on market country: -
Authorised representative: Amstermed B.V.
Last updated: 29.06.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

Operah

Class IIbNot specifiedOn the market

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989099
Basic UDI-DI: B-08908003989099
Reference: nice 5000
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Amstermed B.V.
Last updated: 29.06.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

Wallaby

Class IIbNot specifiedOn the market

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: -
EMDN description: -
First on market country: -
Authorised representative: Amstermed B.V.
Last updated: 29.06.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

iSmart

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

Manufacturer: nice Neotech Medical Systems Pvt. Ltd.,
Manufacturer SRN: IN-MF-000010243
UDI-DI: 08908003989211
Basic UDI-DI: 8908003989nice8050M4
Reference: nice 8010
EMDN: R060201
EMDN description: ACTIVE VENTILATION HUMIDIFICATION SYSTEMS,
First on market country: -
Authorised representative: Amstermed B.V.
Last updated: 29.06.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details