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Organization name
UDI-DI code
Reference / catalog number

Custom pack FACO 2 private — Class IIa MDR by Delta Med SPA

MD Atlas
Delta Med SPA

EUDAMED last updated this device on Dec 19, 2025

Custom pack FACO 2 private

8032248903019X

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Delta Med SPA
UDI-DI code: 08032248903050
Reference / catalog number: 82.H8685.00

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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 2 private
UDI-DI code: 08032248903050
Basic UDI-DI: 8032248903019X
Reference / catalog number: 82.H8685.00
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 composed by: drape for ophthalmology 120x165, EXPO gown sz. L and XL, gauze 10x10, syringes 10ML, 3ML and 5ML, syringe 1ML, graduated transparent bowl 60ml, hurricane small towel, universal occluder, double-layered drape 75x90 with adhesive side 75cm, delta eye care 25G angle 30°/S, white tray, hands microscalpel
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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