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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

OBF - Box 40 UN — Class I MDR by FAMADENT, S.L.U.

MD Atlas
FAMADENT, S.L.U.

EUDAMED last updated this device on Oct 27, 2021

OBF - Box 40 UN

84354577-00024W

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FAMADENT, S.L.U.
UDI-DI code: 08435457718154
Reference / catalog number: OBF-040

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Manufacturer information

Organization name: FAMADENT, S.L.U.
SRN: ES-MF-000000270
Manufacturer status: Active

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: OBF - Box 40 UN
UDI-DI code: 08435457718154
Basic UDI-DI: 84354577-00024W
Reference / catalog number: OBF-040
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: 40
Additional product description: Lip retractor
Additional information URL: https://oralbiofilter.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q010599DENTAL INSTRUMENTS, SINGLE-USE - OTHER

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

Related devices

9056-03084354577-00014UOn the market 9056-02084354577-00014UOn the market 9055-020-R184354577-00014UOn the market 9055-020-R1V84354577-00014UOn the market 9055-030-R184354577-00014UOn the market

Certificates

Certificate health across this manufacturer's portfolio.

ES26/000001625Issued
Quality management systemNotified body: 1639Expiry: Feb 16, 2031