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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

IR-10MB — Class IIb MDD by ZAKŁAD URZĄDZEŃ…

MD Atlas
ZAKŁAD URZĄDZEŃ MEDYCZNYCH UNIMED INŻ. ADAM ANDRUSZCZAK

EUDAMED last updated this device on Jun 12, 2023

IR-10MB

B-59043588959168

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ZAKŁAD URZĄDZEŃ MEDYCZNYCH UNIMED INŻ. ADAM ANDRUSZCZAK
UDI-DI code: 59043588959168
Reference / catalog number: IR-10MB

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View device family (Basic UDI)

Manufacturer information

Organization name: ZAKŁAD URZĄDZEŃ MEDYCZNYCH UNIMED INŻ. ADAM ANDRUSZCZAK
SRN: PL-MF-000008657
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW014
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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	May 1, 2004	Dec 31, 2028

Device identification

Trade name: not provided
UDI-DI code: 59043588959168
Basic UDI-DI: B-59043588959168
Reference / catalog number: IR-10MB
Issuing entity: GS1

Classification

Risk category: Class IIb
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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)59043588959168

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z12080407NEONATAL RADIANT WARMERS

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

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Related devices

SRN-10MB-59043588959182On the market SRN-10B-59043588959175On the market SRN-10/SFTB-59043588959267On the market SRN-10M/SFTB-59043588959274On the market IR-10B-59043588959151On 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.