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Totally Remove
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref TO01310Ref TOEC1310CRef TOEC0810CRef TOEC1315CRef TO1315Ref TO1306Ref TOEC1110CRef TO1115C
Identity
- Trade Name
- TOTALLY REMOVE EUDAMEDBIOPSYBELL SRL FDA UDI
- Generic Name
- Bone marrow biopsy procedure kit FDA UDI
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMEDNeedle for bone-marrow biopsy FDA UDI
- Model / Reference
- TO01310 EUDAMEDTOEC1310C EUDAMEDTOEC0810C EUDAMEDTOEC1315C EUDAMEDTO1315 EUDAMEDTO1306 EUDAMEDTOEC1110C EUDAMEDTO1115C EUDAMEDTOTALLY REMOVE FDA UDI
- Description
- Needle for bone-marrow biopsy FDA UDI
Identifiers
- Catalog Number
- TO1315 FDA UDI
- Primary DI / UDI-DI
- 08033860027520 EUDAMED08033860017408 EUDAMED08033860001902 EUDAMED08033860002459 EUDAMED08033860015091 EUDAMEDFDA UDI08033860013257 EUDAMED08033860002350 EUDAMED08033860040802 EUDAMED
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMED
- 510(k) Number
- K130616 FDA UDI
- FDA Product Code
- FCG FDA UDIKNW FDA UDI
- EMDN Code
- A01020201 ILIAC-STERNAL BIOPSY NEEDLES AND KITS EUDAMED
- GMDN Term
- Bone marrow biopsy procedure kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 13 Gauge FDA UDILength — 150 Millimeter FDA UDI
Totally Remove by Biopsybell Srl — 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 | 8033860BIOEFT01U5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (9)
- EUDAMED 65db4976-79bf-467a-a0e7-58d92efc4266 61 fields · synced Jul 21, 2026
- EUDAMED e1e36859-0d85-426f-a7ed-2129aa1b73d3 61 fields · synced May 16, 2026
- EUDAMED 5117f717-8a62-4513-8cda-d99eee1327c6 61 fields · synced May 16, 2026
- EUDAMED 26008841-2c75-40d5-a842-eb225e4ef009 61 fields · synced May 16, 2026
- EUDAMED ec32f494-265b-4572-9240-b5be79713ec4 61 fields · synced May 17, 2026
- EUDAMED f6f97cf6-ee77-4cc0-8315-0bc16809791e 61 fields · synced May 18, 2026
- EUDAMED 1b3c6e44-bd1e-47da-9580-0895087cd407 61 fields · synced May 18, 2026
- EUDAMED 1426d884-49e5-40b5-8c03-d08f5103f399 61 fields · synced May 18, 2026
- FDA UDI 6d84c40a-8ff3-4d6c-aca1-15c80953da4f 37 fields · synced May 30, 2026