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META+ SYSTEM Spinal Cement System

EUDAMEDFDA UDI

Class III (EU MDR)

Ref T040352MV

by Teknimed Sas

Identity

Trade Name
META+ SYSTEM Spinal Cement System EUDAMED
META+ System 1.5cc MV FDA UDI
Generic Name
Orthopaedic cement preparation/delivery kit FDA UDI
Device Name
PUREKIT MV EUDAMED
Model / Reference
T040352MV EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
03701505801037 EUDAMEDFDA UDI
Basic UDI-DI
376017704B34D9 EUDAMED
FDA Product Code
NDN FDA UDI
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 III EUDAMED
Class II FDA UDI
Regulation Number
888.3027 FDA UDI
888.4200 FDA UDI
888.4210 FDA UDI
Medical Purpose
The system is intended 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

META+ SYSTEM Spinal Cement System by Teknimed Sas — Class III — 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 32f6b15e-6791-4355-9850-32e2b0c1e793 61 fields · synced Jun 19, 2026
  • FDA UDI b69cd0fe-fa26-4b22-b130-dbd77aa2ca0e 32 fields · synced May 30, 2026