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Ester & Introduttore
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GUNTR1825ECRef GUN1610ECRef GUN1820ECRef GUN1620ECRef GUN1807ECRef GUN1420EC10Ref GUN1410ECRef GUN1825ECRef GUN1825EC10Ref GUN1620EC10Ref GUNTR1410EC10Ref GUNTR1412EC
Identity
- Trade Name
- ESTER & INTRODUTTORE EUDAMEDESTER EUDAMEDBiopsybell FDA UDI
- Generic Name
- End-cut biopsy gun handpiece/needle FDA UDI
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMEDESTER EUDAMEDSOFT TISSUES BIOPSY NEEDLES (SEMIAUTOMATIC AND AUTOMATIC) EUDAMEDAUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY FDA UDIAutomatic guillotine needle for soft tissue biopsy FDA UDI
- Model / Reference
- GUNTR1825EC EUDAMEDGUN1610EC EUDAMEDGUN1820EC EUDAMEDGUN1620EC EUDAMEDGUN1807EC EUDAMEDGUN1420EC10 EUDAMEDGUN1410EC EUDAMEDGUN1825EC EUDAMEDGUN1825EC10 EUDAMEDGUN1620EC10 EUDAMEDGUNTR1410EC10 EUDAMEDGUNTR1412EC EUDAMEDESTER FDA UDIESTER & INTRODUTTORE FDA UDI
- Description
- AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY FDA UDIAutomatic guillotine needle for soft tissue biopsy FDA UDI
Identifiers
- Catalog Number
- GUN1620EC FDA UDIGUN1825EC FDA UDIGUN1820EC FDA UDIGUNTR1825EC FDA UDIGUN1610EC FDA UDIGUN1410EC FDA UDI
- Primary DI / UDI-DI
- 08033860011550 EUDAMEDFDA UDI08033860003609 EUDAMEDFDA UDI08033860003647 EUDAMEDFDA UDI08033860003166 EUDAMEDFDA UDI08033860016012 EUDAMED08033860024604 EUDAMED08033860003067 EUDAMEDFDA UDI08033860010157 EUDAMEDFDA UDI08033860024680 EUDAMED08033860020521 EUDAMED08033860003326 EUDAMED08033860011598 EUDAMED
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMEDB-08033860003647 EUDAMEDB-08033860003166 EUDAMEDB-08033860010157 EUDAMEDB-08033860003609 EUDAMEDB-08033860003067 EUDAMED8033860BIOAFT01SR 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 — 150 Millimeter FDA UDINeedle Gauge — 14 Gauge FDA UDILength — 250 Millimeter FDA UDINeedle Gauge — 18 Gauge FDA UDILength — 200 Millimeter FDA UDILength — 100 Millimeter FDA UDI
Ester & Introduttore by Biopsybell Srl — Class IIa — 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 | 8033860BIOEFT01U5 | Class IIa | Active |
| 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 (29)
- EUDAMED c4a3606d-6250-48c2-bafe-2c186c352e0b 61 fields · synced Jul 29, 2026
- EUDAMED f369edb8-d6db-4500-badd-313727e5ee94 61 fields · synced May 17, 2026
- EUDAMED 69ba3fe0-3f99-4157-9fc6-9664d06f7a51 61 fields · synced May 17, 2026
- EUDAMED 2b0e5770-5e01-4885-bcad-b16348990e74 61 fields · synced May 17, 2026
- EUDAMED ca982fb7-ca9f-4ec9-9cf6-0669b242b809 61 fields · synced May 17, 2026
- EUDAMED c8e33c14-c59a-4464-8826-1fa98dd3a64f 61 fields · synced May 18, 2026
- EUDAMED 039bb04c-8cbb-482a-beaf-56fd78b1dccf 61 fields · synced May 18, 2026
- EUDAMED 05de292a-7eaf-44c5-815d-ab5a55eee4b2 61 fields · synced May 18, 2026
- EUDAMED aabae265-7e1e-4d6e-94d5-446f1cfdcc54 61 fields · synced May 18, 2026
- EUDAMED 201aa61c-993b-41c7-9f64-b9b3d4e8086d 61 fields · synced May 18, 2026
- EUDAMED c877788a-feb8-44ea-ada3-dcbaae67e869 61 fields · synced May 18, 2026
- EUDAMED 41753675-0ee3-4160-9293-9648eb0b0f57 61 fields · synced May 18, 2026
- EUDAMED 8f322855-e9f2-4be1-a821-63880d8a5052 61 fields · synced May 18, 2026
- EUDAMED 10ee1071-419a-4799-8a07-5970ead3ff43 61 fields · synced May 18, 2026
- EUDAMED 6bcd68e1-a07e-4212-9d3a-cc2276d7aef6 61 fields · synced May 19, 2026
- EUDAMED db932a0b-5714-4948-a34d-c0d16929bd40 61 fields · synced May 19, 2026
- EUDAMED d2fd9800-6189-4b2d-a9da-89ad8ba2a147 61 fields · synced May 19, 2026
- FDA UDI cc3081bf-f77d-44bc-90e0-0e86acda567a 37 fields · synced May 29, 2026
- FDA UDI a1be94dd-072c-42d9-a717-c214d4652bc9 37 fields · synced May 29, 2026
- FDA UDI b1d124ee-f71c-4983-bcdd-0148e788521d 37 fields · synced May 30, 2026
- FDA UDI ed0e0457-dd85-4c18-ab37-51845318a361 37 fields · synced May 30, 2026
- FDA UDI 9e55db9b-8939-4e1b-94fc-536e089c0dc5 37 fields · synced May 30, 2026
- FDA UDI 560c3f80-299d-40ba-a22f-58e5b9f5d640 37 fields · synced May 30, 2026
- EUDAMED 2afd7aa6-3188-460e-9404-1638c46c3ab7 61 fields · synced Jun 19, 2026
- EUDAMED 595b20d0-93c7-42ef-94ff-f7d75c8e91f3 61 fields · synced Jul 8, 2026
- EUDAMED df7b1839-edff-4826-b14b-39a09f0ed14d 61 fields · synced Jul 8, 2026
- EUDAMED 90d41aea-df18-4229-a7d2-0baecefd8463 61 fields · synced Jul 21, 2026
- EUDAMED 24d956e5-0f62-4c8a-9f62-a79fcae681c8 61 fields · synced Jul 23, 2026
- EUDAMED 6f2501d8-5340-4c2d-9396-05466c43d58f 61 fields · synced Jul 27, 2026