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Organization name
UDI-DI code
Reference / catalog number

Custom pack FACO 1 Private — Class IIa MDR by Delta Med SPA

MD Atlas
Delta Med SPA

EUDAMED last updated this device on Jan 29, 2026

Custom pack FACO 1 Private

8032248900019G

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Delta Med SPA
UDI-DI code: 08032248900066
Reference / catalog number: 52.C5324.00

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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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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.

Critical warnings

3 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.

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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: Custom pack FACO 1 Private
UDI-DI code: 08032248900066
Basic UDI-DI: 8032248900019G
Reference / catalog number: 52.C5324.00
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: Custom pack for private customer composed by: two expo gown sz. L, gauze 10x10 4 layers, blue sponge tampon, syringe 3ML L/L (BD), syringe 10ML L/L, hurricane towel, transparent universal eye occluder, hypodermic needle 21G, delta eye care nuc. hydrod 25G 30 degrees, microscalpel 22,5 degrees, microscalpel FACO 2,4mm, aluminium bowl, white tray with 6 compartments, drape 75x90, ophtalmology drape 120x165
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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