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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

80.280 — Class I MDR by Dörr Kampen B.V.

MD Atlas
Dörr Kampen B.V.

EUDAMED last updated this device on Jan 17, 2025

80.280

8721249463MFJY

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dörr Kampen B.V.
UDI-DI code: 08721249463044
Reference / catalog number: 80.280

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View device family (Basic UDI)

Manufacturer information

Organization name: Dörr Kampen B.V.
SRN: NL-MF-000000113
Manufacturer status: Active

Related devices

80.2008721249463MFJYOn the market 1020B-08721249463020On the market 2020B-08721249463013On the market 4020B-08721249463006On the market 50148721249463VAKHOn 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

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

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08721249463044
Basic UDI-DI: 8721249463MFJY
Reference / catalog number: 80.280
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: ManoFlexibilo kind, hulpmiddel bij handoperaties van pees-, vaat- en zenuwletsel, vingerfracturen, evenals bij de behandeling van de ziekte van Dupuytren en het carpaletunnelsyndroom of algemene handverwondingen.
Additional information URL: No additional information URL provided by the manufacturer.
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)08721249463044

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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.

V0804PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)

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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