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MedV+

EUDAMEDFDA UDI

Class I (EU MDR)

Ref T060417

by Teknimed Sas

Identity

Trade Name
MedV+ EUDAMED
MED V+ FDA UDI
Generic Name
Orthopaedic cement preparation/delivery kit FDA UDI
Device Name
MedV+ EUDAMED
Model / Reference
T060417 EUDAMEDFDA UDI

Identifiers

Catalog Number
T060417 FDA UDI
Primary DI / UDI-DI
03760177042186 EUDAMEDFDA UDI
Basic UDI-DI
376017704B30CZ EUDAMED
FDA Product Code
OAR FDA UDI
JDZ FDA UDI
EMDN Code
P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
GMDN Term
Orthopaedic cement preparation/delivery kit FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
888.4200 FDA UDI
888.4210 FDA UDI
Medical Purpose
The system is intended to be used to mix and inject medium viscosity bone cement during cementoplasty procedures. EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MedV+ by Teknimed Sas — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teknimed Sas
EUDAMED SRN
FR-PR-000001226

Sources (2)

  • EUDAMED 51427313-33de-4a6c-be69-a5fec7812ef0 61 fields · synced Jul 27, 2026
  • FDA UDI ef39a2b3-b0ae-46b6-8454-1644fcde3b01 33 fields · synced May 30, 2026