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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

SCR.001 — Class I MDD by Hedera Biomedics S.r.l.

MD Atlas
Hedera Biomedics S.r.l.

EUDAMED last updated this device on Jan 30, 2024

SCR.001

B-805714366SCR001AVNQ

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Hedera Biomedics S.r.l.
UDI-DI code: D-805714366SCR001AVNQ
Reference / catalog number: SCR.001

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Manufacturer information

Organization name: Hedera Biomedics S.r.l.
SRN: IT-MF-000039831
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: D-805714366SCR001AVNQ
Basic UDI-DI: B-805714366SCR001AVNQ
Reference / catalog number: SCR.001
Issuing entity: EUDAMED

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: 2 indipendent channels auditory evoked potentials system
Additional information URL: https://www.hederabiomedics.com/en/auditory-evoked-potentials-socrates_4.htm
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-805714366SCR001AVNQ

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

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

Z12140380EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - HARDWARE ACCESSORIES

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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Related devices

SCR.002B-805714366SCR002AXNZOn the market

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.