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Vacuukit
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref T060416Model Vacuum Mixing & Injection System for bone cement
by Teknimed Sas
Identity
- Trade Name
- VACUUKIT EUDAMEDODONCER FDA UDI
- Generic Name
- Dental bone matrix implant, synthetic FDA UDI
- Device Name
- VACUUKIT EUDAMED
- Model / Reference
- Vacuum Mixing & Injection System for bone cement EUDAMEDT060416 EUDAMED100-1000µm 2cc FDA UDI
Identifiers
- Catalog Number
- T8210102 FDA UDI
- Primary DI / UDI-DI
- 03760177042919 EUDAMEDFDA UDI
- Basic UDI-DI
- 376017704B21CY EUDAMED
- FDA Product Code
- LYC FDA UDI
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
- GMDN Term
- Dental bone matrix implant, synthetic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 3.2 Gram FDA UDIPore Size — 220 Micrometer FDA UDI
Vacuukit by Teknimed Sas — Class IIa — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 376017704B21CY | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Teknimed Sas
- EUDAMED SRN
- FR-MF-000001224
Sources (2)
- EUDAMED c17052bb-cf0d-4934-982a-edf90c6d9a29 61 fields · synced Jun 18, 2026
- FDA UDI 397566d0-df2b-4269-982d-0e16a5764c20 35 fields · synced May 29, 2026