Identity
- Trade Name
- ESTER EUDAMEDBiopsybell FDA UDI
- Generic Name
- End-cut biopsy gun handpiece/needle FDA UDI
- Device Name
- ESTER EUDAMEDNEEDLES FOR BIOPSY OR EXPLANT EUDAMEDAUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY FDA UDI
- Model / Reference
- GUN1810EC EUDAMEDESTER FDA UDI
- Description
- AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY FDA UDI
Identifiers
- Catalog Number
- GUN1810EC FDA UDI
- Primary DI / UDI-DI
- 08033860006617 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033860006617 EUDAMED8033860BIOEFT01U5 EUDAMED
- 510(k) Number
- K130616 FDA UDI
- FDA Product Code
- FCG FDA UDIKNW FDA UDI
- EMDN Code
- A0102010102 SHEARING BIOPSY GUNS EUDAMED
- GMDN Term
- End-cut biopsy gun handpiece/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
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
- Length — 100 Millimeter FDA UDINeedle Gauge — 18 Gauge FDA UDI
Ester by Biopsybell Srl — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-08033860006617 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860006617 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (3)
- EUDAMED 3eeab9c3-7999-4e35-b143-1aeb5c72a222 61 fields · synced Jun 18, 2026
- EUDAMED d9172899-a029-492c-b6bf-de84ebaecff3 61 fields · synced May 17, 2026
- FDA UDI 87ec2722-2ff7-4e37-ac35-ad5367d86079 37 fields · synced May 30, 2026