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Organization name
UDI-DI code
Reference / catalog number

Custom pack for spinal… — Class IIa MDR by Delta Med SPA

MD Atlas
Delta Med SPA

EUDAMED last updated this device on Apr 9, 2026

Custom pack for spinal interventional radiology

803224890501A9

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Delta Med SPA
UDI-DI code: 08032248905054
Reference / catalog number: 82.H8695.00

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View device family (Basic UDI)

Manufacturer information

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

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.

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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 for spinal interventional radiology
UDI-DI code: 08032248905054
Basic UDI-DI: 803224890501A9
Reference / catalog number: 82.H8695.00
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: Drape 150x150cm, gown in SMS sz XL, elastic sleeve/cover 90cm, single drape for spinal surgery, pack of 25 gauze 10x10cm, blue sponge swab with handle, scalpel, 10ml syringe with hypodermic needle 22G, 5ml syringe with hypodermic needle 21G, yellow bowl 250ml, blue bowl 500ml, blu bowl 1000ml.
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.

T0202SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS)

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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