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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

4640/4641 — Class I MDR by Prova Nova GmbH

MD Atlas
Prova Nova GmbH

EUDAMED last updated this device on Nov 2, 2024

4640/4641

4250551600000084V

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Prova Nova GmbH
UDI-DI code: 04250551699093
Reference / catalog number: 4640/4641

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Manufacturer information

Organization name: Prova Nova GmbH
SRN: DE-MF-000017745
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 04250551699093
Basic UDI-DI: 4250551600000084V
Reference / catalog number: 4640/4641
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: "Handwerklich gepolsterter Sattelsitz, Sitzbreite ca. 430 mm, Sitztiefe ca. 350 mm, Sitzhöhe ca. 200 mm, Sitzstärke ca. 60 mm, Sitzkern aus PUR/Schaumstoff. Atmungsaktiver Sitzbezug mit antimikrobielle und antivirale Wirkung für besten Sitzkomfort bei jedem Klima, phthalate-frei, kratz- und abriebfest sowie desinfektionsmittelbeständig = lange Haltbarkeit Bezugsmaterial Stamskin ZEN (Mehrschichtverbund, Träger Polyamid-Jersey) Feuersicherheit: NF EN 1021 1+2, DIN 53438 T 2. Bei sachgemäßer Anwendung sind nach DIN EN ISO 10993-5 keine zytotoxischen Effekte und nach DIN EN ISO 10993-10 keine primären Hautirritationen zu erwarten Zwei Hebel-Auslösemechanik, stufenlos höhenverstellbare Sicherheits-Gasfedersäule mit Tiefenfederung, Sitzneigeverstellung nach vorn, Poliertes Aluminum-Fußkreuz Ø ca. 610 mm Rollen ø ca. 75 mm, Rollenbreite ca. 23 mm, Einrad-Lenkrolle, Gehäuse aus Polyamid, Schwenklager mit Gleitlager, Farbe: RAL 9011 (Graphitschwarz), Rad mit Kugellager und spurfreier transparenter Polyurtehanbereifung (TPU), Shorehärte ca. 80A, Reinigung durch Wischdesinfektion uneingeschränkt möglich, Tragfähigkeit ca. 135 kg"
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040280GENERAL MEDICINE THERAPEUTIC TREATMENT 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.