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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Breast-SlimView® — Class IIa MDD by Hera-MI

MD Atlas
Hera-MI

EUDAMED last updated this device on Apr 29, 2022

Breast-SlimView®

B-37700160100094

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Hera-MI
UDI-DI code: 37700160100094
Reference / catalog number: Breast-SlimView®

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Manufacturer information

Organization name: Hera-MI
SRN: FR-MF-000007290
Manufacturer status: Active

Market distribution

Primary placement in France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Sweden		Still on market

Device identification

Trade name: not provided
UDI-DI code: 37700160100094
Basic UDI-DI: B-37700160100094
Reference / catalog number: Breast-SlimView®
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

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

EMDN nomenclature code(s)

Z119082VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - SOFTWARE ACCESSORIES

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

Related devices

This device is not currently linked to any other device.

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.