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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

CUSTOM PACK FOR INTRAVITREAL… — Class IIa MDR by Surgika srl

MD Atlas
Surgika srl

EUDAMED last updated this device on May 13, 2026

CUSTOM PACK FOR INTRAVITREAL INJECTIONS

805961777PPSOPHXR

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Surgika srl
UDI-DI code: 08059617772963
Reference / catalog number: C03OPH0077

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View device family (Basic UDI)

Manufacturer information

Organization name: Surgika srl
SRN: IT-MF-000024206
Manufacturer status: Active

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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 INTRAVITREAL INJECTIONS
UDI-DI code: 08059617772963
Basic UDI-DI: 805961777PPSOPHXR
Reference / catalog number: C03OPH0077
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 PER INIEZIONI INTRAVITREALI-CUSTOM PACK FOR INTRAVITREAL INJECTIONS
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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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.