EUDAMED last updated this device on May 23, 2025

Soft band, bilateral, Black

57121491000386

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Oticon Medical AB
UDI-DI code: 05712149002177
Reference / catalog number: M50736

Soft band, bilateral, Black is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Oticon Medical AB. Placed on the EU market in Sweden. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Role
Country
Date of registration
Address

EUDAMED last updated this device on May 23, 2025

Soft band, bilateral, Black

57121491000386

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Oticon Medical AB
UDI-DI code: 05712149002177
Reference / catalog number: M50736

View device family (Basic UDI)

Device identification

Trade name: Soft band, bilateral, Black
UDI-DI code: 05712149002177
Basic UDI-DI: 57121491000386
Reference / catalog number: M50736
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.oticonmedical.com/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05712149002177

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Y214599HEARING AIDS - OTHER

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in Sweden; available across 16 countries total.

Country	On market since	Until
SwedenPrimary placement		Still on market
Austria		Still on market
Belgium		Still on market
Germany		Still on market
Denmark		Still on market
EL		Still on market
Spain		Still on market
France		Still on market
Hungary		Still on market
Ireland		Still on market
Italy		Still on market
Netherlands		Still on market
Norway		Still on market
Poland		Still on market
Portugal		Still on market
XI		Still on market

Device identification

Trade name: Soft band, bilateral, Black
UDI-DI code: 05712149002177
Basic UDI-DI: 57121491000386
Reference / catalog number: M50736
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.oticonmedical.com/
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: Oticon Medical AB
SRN: SE-MF-000000724
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05712149002177

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Y214599HEARING AIDS - OTHER

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

Certificates

Certificate health across this manufacturer's portfolio.

G10 106872 0003Issued
Quality management systemNotified body: 0123Expiry: Jul 18, 2026

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

All products by Oticon Medical AB

Market distribution

Primary placement in Sweden; available across 16 countries total.

Country	On market since	Until
SwedenPrimary placement		Still on market
Austria		Still on market
Belgium		Still on market
Germany		Still on market
Denmark		Still on market
EL		Still on market
Spain		Still on market
France		Still on market
Hungary		Still on market
Ireland		Still on market
Italy		Still on market
Netherlands		Still on market
Norway		Still on market
Poland		Still on market
Portugal		Still on market
XI		Still on market

Soft band, bilateral, Black

Soft band, bilateral, Black

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates covering this device

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

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