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06945429021127

Class IIbNot specifiedOn the marketActive deviceMeasuring function

Manufacturer: Shenzhen Comen Medical Instruments Co.,LTD.
Manufacturer SRN: CN-MF-000002236
UDI-DI: 06945429021127
Basic UDI-DI: 69454290BQ002KE
Reference: BQ80A
EMDN: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
First on market country: Belgium
Authorised representative: Lotus NL B.V.
Last updated: 12.07.2026 09:11

Manufacturer products Authorised representative products Authorised representative actors View details

Comfort Shells

Class IMDDOn the market

Manufacturer: Naturalnco
Manufacturer SRN: FR-MF-000053555
UDI-DI: 37700429190002
Basic UDI-DI: B-37700429190002
Reference: CoquilleS
EMDN: Z12080399
EMDN description: VARIOUS CHILDBIRTH SUPPORT AND MATERNAL ASSISTANCE INSTRUMENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:52

Manufacturer products View details

SATIS +

3600

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: MEDIPREMA
Manufacturer SRN: FR-MF-000011274
UDI-DI: D-3600AJ
Basic UDI-DI: B-3600AJ
Reference: 3600
EMDN: Z1208040301
EMDN description: FIXED NEONATAL INCUBATORS
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:37

Manufacturer products View details

D-35.71-3490YV

ECOtwin LED

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: medical ECONET GmbH
Manufacturer SRN: DE-MF-000004982
UDI-DI: D-35.71-3490YV
Basic UDI-DI: B-35.71-3490YV
Reference: 35.71-3490
EMDN: Z12080101
EMDN description: FOETAL MONITORS
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 18:36

Manufacturer products View details

D-35.71-3480YS

ECOtwin LCD

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: medical ECONET GmbH
Manufacturer SRN: DE-MF-000004982
UDI-DI: D-35.71-3480YS
Basic UDI-DI: B-35.71-3480YS
Reference: 35.71-3480
EMDN: Z12080101
EMDN description: FOETAL MONITORS
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 18:36

Manufacturer products View details

D-35.71-2600Y5

ECOsound

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: medical ECONET GmbH
Manufacturer SRN: DE-MF-000004982
UDI-DI: D-35.71-2600Y5
Basic UDI-DI: B-35.71-2600Y5
Reference: 35.71-2600
EMDN: Z12080103
EMDN description: FOETAL HEARTBEAT DETECTORS
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 18:36

Manufacturer products View details

D-35.11-7000V4

Smart 1

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: medical ECONET GmbH
Manufacturer SRN: DE-MF-000004982
UDI-DI: D-35.11-7000V4
Basic UDI-DI: B-35.11-7000V4
Reference: 35.11-7000
EMDN: Z12080101
EMDN description: FOETAL MONITORS
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 18:36

Manufacturer products View details

D-35.11-4200UR

Smart 3

Class IIbMDDOn the marketActive deviceMeasuring function

Manufacturer: medical ECONET GmbH
Manufacturer SRN: DE-MF-000004982
UDI-DI: D-35.11-4200UR
Basic UDI-DI: B-35.11-4200UR
Reference: 35.11-4200
EMDN: Z12080101
EMDN description: FOETAL MONITORS
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 18:36

Manufacturer products View details

FETAL SPIRAL ELECTRODE

FSE and Fetal Double Spiral Electrode

Class IIaMDDOn the marketActive deviceMeasuring functionSingle useSterile

Manufacturer: Philips Medical Systems
Manufacturer SRN: US-MF-000002321
UDI-DI: 20884838007431
Basic UDI-DI: B-20884838007431
Reference: 989803137631
EMDN: Z12080101
EMDN description: FOETAL MONITORS
First on market country: Austria
Authorised representative: Philips Medical Systems Nederland B.V.
Last updated: 11.07.2026 15:05

Manufacturer products Authorised representative products Authorised representative actors View details

mamivac® Stillhütchen

Cherry-shaped, M (22 mm)

Class IIaMDDOn the market

Manufacturer: Kimetec GmbH
Manufacturer SRN: DE-MF-000006493
UDI-DI: 14250373654949
Basic UDI-DI: B-14250373654949
Reference: 281482
EMDN: Z12080399
EMDN description: VARIOUS CHILDBIRTH SUPPORT AND MATERNAL ASSISTANCE INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 07:57

Manufacturer products 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

Manufacturer products Authorised representative products Authorised representative actors View details

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

08906033940301

Nymphaea

Class IIaMDDOn the marketActive device

Manufacturer: Phoenix Medical Systems Pvt. Ltd
Manufacturer SRN: IN-MF-000022931
UDI-DI: 08906033940301
Basic UDI-DI: B-08906033940301
Reference: 7.2.3‐47
EMDN: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

08906033940288

Brillance Bottom

Class IIbMDDOn the marketActive device

Manufacturer: Phoenix Medical Systems Pvt. Ltd
Manufacturer SRN: IN-MF-000022931
UDI-DI: 08906033940288
Basic UDI-DI: B-08906033940288
Reference: 7.2.3‐30B
EMDN: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

08906033940257

NRC 100

Class IIbMDDOn the marketActive device

Manufacturer: Phoenix Medical Systems Pvt. Ltd
Manufacturer SRN: IN-MF-000022931
UDI-DI: 08906033940257
Basic UDI-DI: B-08906033940257
Reference: 7.2.3‐11A
EMDN: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

08906033940271

LED PT 100

Class IIaMDDOn the marketActive device

Manufacturer: Phoenix Medical Systems Pvt. Ltd
Manufacturer SRN: IN-MF-000022931
UDI-DI: 08906033940271
Basic UDI-DI: B-08906033940271
Reference: 7.2.3‐22
EMDN: Z12080401
EMDN description: PAEDIATRIC PHOTOTHERAPY EQUIPMENT
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

08906033940264

INC 200

Class IIbMDDOn the marketActive device

Manufacturer: Phoenix Medical Systems Pvt. Ltd
Manufacturer SRN: IN-MF-000022931
UDI-DI: 08906033940264
Basic UDI-DI: B-08906033940264
Reference: 7.2.3‐35
EMDN: Z1208040302
EMDN description: MOBILE NEONATAL INCUBATORS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

08906033940240

WMW 100

Class IIbMDDOn the marketActive device

Manufacturer: Phoenix Medical Systems Pvt. Ltd
Manufacturer SRN: IN-MF-000022931
UDI-DI: 08906033940240
Basic UDI-DI: B-08906033940240
Reference: 7.2.3‐26
EMDN: Z12080407
EMDN description: NEONATAL RADIANT WARMERS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details