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Organization name
UDI-DI code
Reference / catalog number

WS-1 Single Head Stethoscope — Class I MDR by B.Well Swiss AG

MD Atlas
B.Well Swiss AG

EUDAMED last updated this device on Dec 18, 2023

WS-1 Single Head Stethoscope

764015639MDN1207_2U9

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: B.Well Swiss AG
UDI-DI code: 07640156396034
Reference / catalog number: 1101366

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Manufacturer information

Organization name: B.Well Swiss AG
SRN: CH-MF-000012588
Manufacturer status: Active

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Market distribution

Primary placement in Bulgaria; available across 2 countries total.

Country	On market since	Until
BulgariaPrimary placement		Still on market
Romania		Still on market

Device identification

Trade name: WS-1 Single Head Stethoscope
UDI-DI code: 07640156396034
Basic UDI-DI: 764015639MDN1207_2U9
Reference / catalog number: 1101366
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: WS-1 Single-head stethoscope, bordeaux
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

C9005PHONENDOSCOPES AND STETHOSCOPES

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

44911220852Supplemented
Quality management systemNotified body: 0044Expiry: Nov 12, 2029