Identity
- Trade Name
- MARROW-SET EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Bone marrow explant needle FDA UDI
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMEDASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE FDA UDI
- Model / Reference
- MSE1310C-US EUDAMEDBONE MARROW MSC ASPIRATION KIT Marrow-Set FDA UDI
- Description
- ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE FDA UDI
Identifiers
- Catalog Number
- MSE1310C-US FDA UDI
- Primary DI / UDI-DI
- 08033860036676 EUDAMEDFDA UDI
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMED
- 510(k) Number
- K203397 FDA UDI
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A01020202 BONE MARROW EXPLANT NEEDLES AND KITS EUDAMED
- GMDN Term
- Bone marrow explant needle 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
No
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 — 100 Millimeter FDA UDI
Category: Bone marrow biopsy needle, single-use
Marrow-Set by Biopsybell Srl — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone marrow biopsy needle, single-use.
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- Monoject — Cardinalhealth · Class II
- MEDLOCK — Medax Unipersonale Srl · Class II
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- Faset — Dio Medical Co., Ltd. · U
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 (2)
- EUDAMED 9217b122-bcb5-46d2-bd4a-664473415edc 61 fields · synced May 30, 2026
- FDA UDI a7b2633a-75cb-4d20-9e1a-4a138130ef07 36 fields · synced May 30, 2026