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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

neutral charge & dry R — Class I MDR by MG DEVELOPPEMENT

MD Atlas
MG DEVELOPPEMENT

EUDAMED last updated this device on Jul 22, 2024

neutral charge & dry R

37005607HEARTD4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MG DEVELOPPEMENT
UDI-DI code: 03700560718717
Reference / catalog number: 1 HEART/B&C-138A

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Manufacturer information

Organization name: MG DEVELOPPEMENT
SRN: FR-MF-000012708
Manufacturer status: —

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Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
France		Still on market

Device identification

Trade name: neutral charge & dry R
UDI-DI code: 03700560718717
Basic UDI-DI: 37005607HEARTD4
Reference / catalog number: 1 HEART/B&C-138A
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: NEUTRAL EU variant build box (case, base, gift box, IFU, USB-C cable, PWS EU)
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y214580HEARING AIDS OR HEARING DEVICES - 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

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.