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Dr. INVIVO

by ROKIT HEALTHCARE Inc.

Ref 4D2D100

Dr. INVIVO (4D2D100) is a medical device (EU MDR Class I; EMDN category wound treatment equipment) made by Rokit Healthcare Inc., registered in EUDAMED on 10 Apr 2025 (Basic UDI-DI 880969250DRINVIVOPZ), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880969250DRINVIVOPZ Basic UDI-DI 08809692501008UDI-DIDate10 Apr 2025RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
4D2D100
Primary DI / UDI-DI
08809692501008
Basic UDI-DI
880969250DRINVIVOPZ
Direct marketing DI
08809692501008
EMDN code
Z12019003 Wound treatment equipment
Device class
Class I
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
KR-MF-000009720
Authorised representative
AR Experts B.V. NL-AR-000023989

Similar devices in this category

Other devices filed under WOUND TREATMENT EQUIPMENT.

Other devices from Rokit Healthcare Inc.

Properties

Other properties (14, all answered No)