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Easynject
EUDAMEDFDA UDIClass I (EU MDR)
Ref BBR-KVTGUNRef KVTGUN-DS1Ref KVTGUN-DSRef KVTGUN-DSB
Identity
- Trade Name
- EASYNJECT EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- ACCESSORIES FOR BONE AUGMENTATION MATERIAL INJECTION EUDAMEDEASYNJECT EUDAMEDDevice for cement infusion in the vertebroplasty procedures FDA UDI
- Model / Reference
- BBR-KVTGUN EUDAMEDKVTGUN-DS1 EUDAMEDKVTGUN-DS EUDAMEDKVTGUN-DSB EUDAMEDEASYNJECT FDA UDI
- Description
- Device for cement infusion in the vertebroplasty procedures FDA UDI
Identifiers
- Catalog Number
- KVTGUN-DS1 FDA UDIKVTGUN-DS FDA UDI
- Primary DI / UDI-DI
- 08033860025144 EUDAMED08033860036584 EUDAMEDFDA UDI08033860010843 EUDAMEDFDA UDI08033860024956 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A1S3Z EUDAMEDB-08033860036584 EUDAMEDB-08033860025144 EUDAMEDB-08033860010843 EUDAMED
- FDA Product Code
- OAR 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
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Easynject by Biopsybell Srl — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8033860KYPFT05A1S3Z | Class I | Active |
| EUDAMED | European Union | CE/MDR | 8033860KYPFT05A1S3Z | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (9)
- EUDAMED 33bd3950-a6fc-4fd9-8599-22c763487013 61 fields · synced Sep 17, 2026
- EUDAMED ec68cef1-0422-4950-b6ec-4f77bc38c2af 61 fields · synced May 17, 2026
- EUDAMED 65cd6900-13a4-48a9-b634-2497db216c82 61 fields · synced May 17, 2026
- EUDAMED b90120e2-912b-4413-a2ec-c32b805442c5 61 fields · synced May 17, 2026
- FDA UDI fcb4eb43-e7b1-46a8-ae04-5c5ae96ddc13 35 fields · synced May 30, 2026
- FDA UDI 449c18ad-02a4-4dda-98bb-64c72f45161a 35 fields · synced May 30, 2026
- EUDAMED 4f111b61-c037-4a8b-82c2-30ea0d894d03 61 fields · synced Jul 13, 2026
- EUDAMED 68e928f0-2bbe-470e-925a-8991d7843700 61 fields · synced Jul 24, 2026
- EUDAMED 9150ae39-541f-4852-b0e0-6a285003d3ed 61 fields · synced Sep 17, 2026