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Photonics Healthcare B.V.

Active in EUDAMED

Netherlandsfrom SRN EUDAMED SRN NL-MF-000000802

Devices
2
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor

What Photonics Healthcare B.V. makes

Photonics Healthcare B.V. manufactures the COMET14, a device for measuring tissue oxygenation by determining partial pressure of oxygen in millimeters of mercury, along with the COMET Sensor Holder for securing measurement probes.

The COMET14 is classified as a Class IIa medical device and the COMET Sensor Holder as Class I, both listed in the EU’s eudamed registry. The company is based in the Netherlands.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • COMET14 Ref 0014

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa
  • COMET Sensor Holder Ref 1017

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Company details

EUDAMED SRN
NL-MF-000000802
EU VAT number
NL8197.14.495.B01
EUDAMED status
Active
EUDAMED registered name
Photonics Healthcare B.V.
EUDAMED abbreviated name
Photonics Healthcare BV
Registered address
17, Burgemeester Verderlaan, 3544AD, Utrecht, Netherlands
PRRC contact
Ninke Bourgonjon(public in EUDAMED)

From the company website

Read 18 Oct 2026

The CE-marked COMET measurement system determines oxygen availability as partial pressure of oxygen \[mmHg\].

From the manufacturer's own website. Source

Frequently asked questions

How many devices does Photonics Healthcare B.V. have in the registry?

The registry currently lists 2 devices for Photonics Healthcare B.V.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Photonics Healthcare B.V.'s devices?

Among its 2 most recently registered devices, Photonics Healthcare B.V. has devices listed in EUDAMED (2 devices).

What risk classes do Photonics Healthcare B.V.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for Photonics Healthcare B.V.'s devices are Class I and Class IIa. Each device page shows its own class and authorisation.

What are the newest devices from Photonics Healthcare B.V. in the registry?

The most recently registered devices listed for Photonics Healthcare B.V. include COMET14 and COMET Sensor Holder.

Generated automatically from registry data and not verified by a human reviewer.