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Headset ME70 (8 kHz)

8‑75‑770

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315004445
Basic UDI-DI: 5713315NA000975Z
Reference: 8‑75‑770
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:12

Manufacturer products View details

TDH 39 Headphones (HB‑7)

8‑75‑430

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315004438
Basic UDI-DI: 5713315NA000965X
Reference: 8‑75‑430
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:12

Manufacturer products View details

TDH-39, Contra Phone

8-04-16030

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315004230
Basic UDI-DI: 5713315NA001024Z
Reference: 8-75-85300
EMDN: Z12149005
EMDN description: IMPEDANCE METERS FOR THE AUDITORY SYSTEM
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:12

Manufacturer products View details

05713315002649

Disposable Snap Electrodes

Class IMDR 2017/745On the market

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315002649
Basic UDI-DI: 5713315NA0003459
Reference: 8-64-21601
EMDN: Z12140385
EMDN description: EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:12

Manufacturer products View details

Silicone Ear Tips

8-68-31514

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315001666
Basic UDI-DI: 5713315NA001455K
Reference: 8-68-31500
EMDN: Z12149005
EMDN description: IMPEDANCE METERS FOR THE AUDITORY SYSTEM
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:12

Manufacturer products View details

AURICAL Loudspeaker

8‑62‑45200

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315001093
Basic UDI-DI: 5713315NA000675Q
Reference: 8-62-45200
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:12

Manufacturer products View details

05713315000713

Patient Responder

Class IMDR 2017/745On the marketActive device

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315000713
Basic UDI-DI: 5713315NA000285E
Reference: 8-31-190
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:12

Manufacturer products View details

05713315000676

1066 Astera2 Accessories - Insert Earphones

Class IIaMDR 2017/745On the market

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315000676
Basic UDI-DI: 5713315NA000745M
Reference: 8-75-81200
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:12

Manufacturer products View details

05713315000669

1066 Astera2 Accessories - Headphones

Class IIaMDR 2017/745On the market

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315000669
Basic UDI-DI: 5713315NA000785V
Reference: 8-75-780
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:12

Manufacturer products View details

Headset ME70 (12 kHz)

8-75-790

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315000638
Basic UDI-DI: 5713315NA000795X
Reference: 8‑75‑260
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:12

Manufacturer products View details

1066 MADSEN Astera 2

MADSEN Astera 2

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315000577
Basic UDI-DI: 5713315NA000385H
Reference: 8-04-13102
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:12

Manufacturer products View details

05713315000058

1052 Otosuite Accessory

Class IIaMDR 2017/745On the market

Manufacturer: Natus Medical Denmark ApS
Manufacturer SRN: DK-MF-000001617
UDI-DI: 05713315000058
Basic UDI-DI: 5713315NA000755P
Reference: 8-49-75800
EMDN: Z121401
EMDN description: AUDIOMETERS
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:12

Manufacturer products View details

Lenire Tonguetip

TP-101

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Neuromod Devices Limited
Manufacturer SRN: IE-MF-000004261
UDI-DI: 05391540580080
Basic UDI-DI: 539154058TP-101-EU3ZJ
Reference: EU3
EMDN: Z12149099
EMDN description: VARIOUS ENT INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 31.07.2026 10:02

Manufacturer products View details

Lenire Tonguetip

TP-101

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Neuromod Devices Limited
Manufacturer SRN: IE-MF-000004261
UDI-DI: 05391540580073
Basic UDI-DI: 539154058TP-101-EU2ZG
Reference: EU2
EMDN: Z12149099
EMDN description: VARIOUS ENT INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 31.07.2026 10:02

Manufacturer products View details

Lenire Tonguetip

TP-101

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Neuromod Devices Limited
Manufacturer SRN: IE-MF-000004261
UDI-DI: 05391540580066
Basic UDI-DI: 539154058TP-101-EU1ZE
Reference: EU1
EMDN: Z12149099
EMDN description: VARIOUS ENT INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 31.07.2026 10:02

Manufacturer products View details

Lenire

SM-301

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Neuromod Devices Limited
Manufacturer SRN: IE-MF-000004261
UDI-DI: 05391540580059
Basic UDI-DI: 539154058SM-301-EU3XJ
Reference: EU3
EMDN: Z12149099
EMDN description: VARIOUS ENT INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 31.07.2026 10:00

Manufacturer products View details

Lenire

SM-301

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Neuromod Devices Limited
Manufacturer SRN: IE-MF-000004261
UDI-DI: 05391540580042
Basic UDI-DI: 539154058SM-301-EU2XG
Reference: EU2
EMDN: Z12149099
EMDN description: VARIOUS ENT INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 31.07.2026 10:00

Manufacturer products View details

Lenire

SM-301

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Neuromod Devices Limited
Manufacturer SRN: IE-MF-000004261
UDI-DI: 05391540580035
Basic UDI-DI: 539154058SM-301-EU1XE
Reference: EU1
EMDN: Z12149099
EMDN description: VARIOUS ENT INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 31.07.2026 10:00

Manufacturer products View details

Examination cabinet

ENTCmi0102

Class IMDR 2017/745On the marketDirect marking

Manufacturer: ΠΑΠΠΑΣ Ν. & ΣΙΑ ΟΕ
Manufacturer SRN: GR-MF-000016242
UDI-DI: 05214002308100
Basic UDI-DI: 5214002308ENTCmi0201T6
Reference: ENTCmi0201
EMDN: Z121402
EMDN description: ENT TREATMENT UNITS
First on market country: Greece
Authorised representative: -
Last updated: 31.07.2026 09:47

Manufacturer products View details

Examination cabinet

ENTC0102w

Class IMDR 2017/745On the marketDirect marking

Manufacturer: ΠΑΠΠΑΣ Ν. & ΣΙΑ ΟΕ
Manufacturer SRN: GR-MF-000016242
UDI-DI: 05214002308094
Basic UDI-DI: 5214002308ENTC0102wBQ
Reference: ENTC0102w
EMDN: Z121402
EMDN description: ENT TREATMENT UNITS
First on market country: Greece
Authorised representative: -
Last updated: 31.07.2026 09:47

Manufacturer products View details