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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

MeningoFinder® 2SMART — IVDD — Annex II List B IVDD

MD Atlas
PathoFinder B.V.

EUDAMED last updated this device on Jun 15, 2023

MeningoFinder® 2SMART

B-08719327116111

On the marketIVDD — Annex II List B

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: PathoFinder B.V.
UDI-DI code: 08719327116111
Reference / catalog number: PF1200-2S

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Manufacturer information

Organization name: PathoFinder B.V.
SRN: NL-MF-000002704
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	Mar 29, 2016	Still on market

Device identification

Trade name: MeningoFinder® 2SMART
UDI-DI code: 08719327116111
Basic UDI-DI: B-08719327116111
Reference / catalog number: PF1200-2S
Issuing entity: GS1

Classification

Risk category: IVDD — Annex II List B
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The MeningoFinder® 2SMART (Single tube Multiplex Amplification in Real Time) kit is non-automated qualitative multiplex PCR-based test to aid in the diagnosis of meningitis or encephalitis in humans by detecting and differentiating 4 RNA viruses, 8 DNA viruses, 8 species/groups of bacteria and 2 species of fungi: mumps virus, measles virus, human enteroviruses (EV), parechoviruses, herpes simplex virus (HSV) type 1, herpes simplex virus type 2, varicella zoster virus, Epstein–Barr virus, cytomegalovirus, human herpesvirus 6 (HHV-6), HHV-7, HHV-8, Listeria monocytogenes, Staphylococcus aureus, Haemophilus influenzae, Streptococcus pneumoniae, Streptococcus agalactiae, Neisseria meningitidis, Borrelia burgdorferi sensu lato (s.l.) (B. burgdorferi sensu stricto (s.s.), B. afzelii, B. garinii, B. spielmanii, B. bavariensis and B. valaisiana) / B. miyamotoi (not distinguished) [3], Escherichia coli K1, Cryptococcus neoformans s.l. (C. neoformans serotypes A and D: C. neoformans var. neoformans, C. neoformans var. grubii and Filobasidiella neoformans) and Cryptococcus gattii s.l. (C. neoformans serotypes B and C: C. gattii, C. neoformans var Bacillisporus and Filobasidiella neoformans var bacillispora) [4]. The MeningoFinder® 2SMART is for use with LightCycler® 480 / cobas® z480 (Roche), Rotor-Gene® Q / Rotor-Gene® Q MDx (QIAGEN) and QuantStudio™ 5 (Thermo Fisher Scientific).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

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Expiration date
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Software identification

EMDN nomenclature code(s)

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

W0105011103STREP. A DETECTION BY NA REAGENTS
W0105011105STREP. PNEUMONIAE DETECTION BY NA REAGENTS
W0105060403CRYPTOCOCCUS - NA REAGENTS
W0105011503E. COLI DETECTION BY NA REAGENTS
W0105011611NEISSERIA MENINGITIDIS - NA REAGENTS
W0105011610HAEMOPHILUS INFLUENZAE - NA REAGENTS
W0105011305LISTERIA DETECTION BY NA REAGENTS
W0105040524HHV-6,7,8 - NA REAGENTS
W0105040205CMV - NA REAGENTS
W0105040403EBV - NA REAGENTS
W0105040904VARICELLA ZOSTER - NA REAGENTS
W0105040311HSV - NA REAGENTS
W0105040502ENTEROVIRUS - NA REAGENTS
W0105040521PARECHOVIRUS - NA REAGENTS
W0105040704MEASLES - NA REAGENTS
W0105040804MUMPS / PAROTITIS - NA REAGENTS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

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.