Identity
- Trade Name
- MARROW-STEM EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Bone marrow explant needle FDA UDI
- Device Name
- MARROW-STEM EUDAMEDNEEDLES FOR BIOPSY OR EXPLANT EUDAMEDASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE FDA UDI
- Model / Reference
- MWS1110C-US EUDAMEDBONE MARROW MSC ASPIRATION KIT-MARROW-STEM FDA UDI
- Description
- ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE FDA UDI
Identifiers
- Catalog Number
- MWS1110C-US FDA UDI
- Primary DI / UDI-DI
- 08033860036317 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033860036317 EUDAMED8033860BIOEFT01U5 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 10 Centimeter FDA UDINeedle Gauge — 11 Gauge FDA UDI
Category: Bone marrow biopsy needle, single-use
Marrow-Stem by Biopsybell Srl — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone marrow biopsy needle, single-use.
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- Monoject — Cardinalhealth · Class II
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08033860036317 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860036317 | 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 (3)
- EUDAMED 2b18d5bf-88d3-4407-a26f-d0e2c0733883 61 fields · synced Aug 1, 2026
- FDA UDI 9097e2fb-8309-4fa2-86af-94605c8e5cb6 38 fields · synced May 30, 2026
- EUDAMED c6d2a5ad-15f5-4baa-8ef1-527c3c20bd31 61 fields · synced Jul 30, 2026