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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

A063080 — Class IIa MDD by IME-DC GmbH…

MD Atlas
IME-DC GmbH International Medical Equipment - Diabetes Care

EUDAMED last updated this device on Dec 27, 2022

A063080

B-04260155930119

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: IME-DC GmbH International Medical Equipment - Diabetes Care
UDI-DI code: 04260155930119
Reference / catalog number: A063080

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Manufacturer information

Organization name: IME-DC GmbH International Medical Equipment - Diabetes Care
SRN: DE-MF-000010393
Manufacturer status: Active

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW018
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Dec 20, 2019	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260155930119
Basic UDI-DI: B-04260155930119
Reference / catalog number: A063080
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: No additional information URL provided by the manufacturer.
Clinical sizes: 8 MU50
31G

EMDN nomenclature code(s)

A0101010202HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS

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

E53010B-04260155930423On the market A053100B-04260155930058On the market A063060B-04260155930126On the market A063120B-04260155930140On the market A063040B-04260155930164On 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.