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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

100489 — Class I MDR by DÔMES PHARMA

MD Atlas
DÔMES PHARMA

EUDAMED last updated this device on Jan 12, 2024

100489

36665601006392G

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: DÔMES PHARMA
UDI-DI code: 03666560024893
Reference / catalog number: 100489

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Manufacturer information

Organization name: DÔMES PHARMA
SRN: FR-MF-000022211
Manufacturer status: Active

Critical warnings

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

CW999
Do not use on the eyelids, mucosa, genitals or ear canal

Market distribution

Primary placement in Poland; available across 3 countries total.

Country	On market since	Until
PolandPrimary placement		Still on market
Cyprus		Still on market
EL		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03666560024893
Basic UDI-DI: 36665601006392G
Reference / catalog number: 100489
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

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

10063936665601006392GOn the market 10249236665601006392GOn the market 10251936665601006392GOn the market 10249136665601006392GOn 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.