Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

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

MD Atlas
MG DEVELOPPEMENT

EUDAMED last updated this device on Jul 22, 2024

audifon 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: 03700560719776
Reference / catalog number: AUDF1 HEART/B&C-139B

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

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 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: audifon charge & dry R
UDI-DI code: 03700560719776
Basic UDI-DI: 37005607HEARTD4
Reference / catalog number: AUDF1 HEART/B&C-139B
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: AUDIFON US variant build box (case, base, gift box, IFU, USB-C cable, PWS US)
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

Related devices

audifon charge & dry R37005607HEARTD4On the market AUDINELL PerfectDome37005607PERFECTDOMEL3On the market AUDIOLINE PerfectDome37005607PERFECTDOMEL3On the market KINDeasycharger Set 2.037005607HEARTD4On the market neutral charge & dry R37005607HEARTD4On the market

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.