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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

8 436538 552001 — Class IIa MDD by Laboratoire Unither

MD Atlas
Laboratoire Unither

EUDAMED last updated this device on Sep 15, 2025

8 436538 552001

B-843653855200187

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Laboratoire Unither
UDI-DI code: D-843653855200187
Reference / catalog number: 8 436538 552001

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Manufacturer information

Organization name: Laboratoire Unither
SRN: FR-MF-000004062
Manufacturer status: Active

Market distribution

Primary placement in Romania; available across 1 country total.

Country	On market since	Until
RomaniaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-843653855200187
Basic UDI-DI: B-843653855200187
Reference / catalog number: 8 436538 552001
Issuing entity: EUDAMED

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: No clinical sizes registered for this device.

EMDN nomenclature code(s)

R060203INHALATION THERAPY HUMIDIFICATION LIQUIDS
V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
Q03040299EAR IRRIGATION DEVICES - OTHER
Q030103NASAL IRRIGATION SOLUTIONS
Q02030299OPHTHALMOLOGY, LIQUID FLUIDS - 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

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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.