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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

20208105 — Class I MDR by Van der Mark Anti…

MD Atlas
Van der Mark Anti Decubitus Systemen

EUDAMED last updated this device on Jun 22, 2022

20208105

8720256271AD11208RW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Van der Mark Anti Decubitus Systemen
UDI-DI code: 08720256271031
Reference / catalog number: 20208105

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View device family (Basic UDI)

Manufacturer information

Organization name: Van der Mark Anti Decubitus Systemen
SRN: NL-MF-000005763
Manufacturer status: Active

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Critical warnings

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

CW011
Het antidecubitus luchtwisseldruk matras mag ingezet worden bij cliënten met botmetastasen mits er een gelijke druk in het matras bestaat door een statische pomp te gebruiken. Het wordt afgeraden om dit product in te zetten bij cliënten met hoog risico op een dreigende dwarslaesie.

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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: 08720256271031
Basic UDI-DI: 8720256271AD11208RW
Reference / catalog number: 20208105
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: —
Additional information URL: https://www.vandermarkzorghulpmiddelen.nl/downloads/adm-ad-matras/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

V080701ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES

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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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.