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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

Hemodynamics custom pack — Class IIa MDR by Delta Med SPA

MD Atlas
Delta Med SPA

EUDAMED last updated this device on Dec 1, 2025

Hemodynamics custom pack

803224891410AC

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Delta Med SPA
UDI-DI code: 08032248914124
Reference / catalog number: 82.H8590.00

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View device family (Basic UDI)

Manufacturer information

Organization name: Delta Med SPA
SRN: IT-MF-000027962
Manufacturer status: Active

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Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: Hemodynamics custom pack
UDI-DI code: 08032248914124
Basic UDI-DI: 803224891410AC
Reference / catalog number: 82.H8590.00
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Sterile single use custom pack for hemodynamic procedures composed by: expo gown sz. XL, waterproof double-layered drape 100x100, single use waterproof double-layered drape 75x90 with adhesive hole 6x9, gauzes 5x5, 7.5x7.5, centric luer syringe 10ml L/S, syringe 2,5 ml L/S, hypodermic needle 18G and 25G, tampon with blue sponge, waterproof drape 50x50 with adhesive side, blue plastic bowl
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

EMDN nomenclature code(s)

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

V0599CLINICAL PROCEDURES KITS 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

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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.