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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

SN1.1 — IVDR Class B IVDR by S.C. CAMP MEDICA…

MD Atlas
S.C. CAMP MEDICA DISTRIBUTION SRL

EUDAMED last updated this device on Jun 7, 2024

SN1.1

5944759012SEENOWDMIVD00EC

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: S.C. CAMP MEDICA DISTRIBUTION SRL
UDI-DI code: 05944759012974
Reference / catalog number: SN1.1

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View device family (Basic UDI)

Manufacturer information

Organization name: S.C. CAMP MEDICA DISTRIBUTION SRL
SRN: RO-MF-000002110
Manufacturer status: Active

Related devices

See NowB-05944759012448On the market See NowB-05944759012431On the market See NowB-05944759012400On the market See NowB-05944759012127On the market See NowB-05944759012240On 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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Romania; available across 1 country total.

Country	On market since	Until
RomaniaPrimary placement	Jan 1, 2014	Jan 1, 2028

Device identification

Trade name: not provided
UDI-DI code: 05944759012974
Basic UDI-DI: 5944759012SEENOWDMIVD00EC
Reference / catalog number: SN1.1
Issuing entity: GS1

Classification

Risk category: IVDR Class B
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: hCG - test pentru determinarea hCG (Gonadotropinei Corionice Umane) in urina
Additional information URL: https://www.campmedica.ro/
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

Encoded

(01)05944759012974

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

W0102160302HCG - RT & POC

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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