← Back to catalogue
Somacore Verify S
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 900510-USRef 900386-USRef 900394-USRef 900486Ref 900494Ref 900484Ref 900506Ref 900504-USRef 900452Ref 900480Ref 900416-USRef 900380Ref 900492Ref 900480-USRef 900516-USRef 900484-USRef 900392Ref 900490Ref 900512Ref 900496Ref 900434Ref 900432-USRef 900430Ref 900482-USRef 900436Ref 900406
Identity
- Trade Name
- SOMACORE VERIFY S EUDAMEDSOMACORE VERIFY EUDAMEDSOMATEX FDA UDI
- Generic Name
- Soft-tissue biopsy procedure kit, non-medicated FDA UDI
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMED
- Model / Reference
- 900510-US EUDAMED900386-US EUDAMED900394-US EUDAMED900486 EUDAMED900494 EUDAMED900484 EUDAMED900506 EUDAMED900504-US EUDAMED900452 EUDAMED900480 EUDAMED900416-US EUDAMED900380 EUDAMED900492 EUDAMED900480-US EUDAMED900516-US EUDAMED900484-US EUDAMED900392 EUDAMED900490 EUDAMED900512 EUDAMED900496 EUDAMED900434 EUDAMED900432-US EUDAMED900430 EUDAMED900482-US EUDAMED900436 EUDAMED900406 EUDAMEDSOMACORE VERIFY S FDA UDI
Identifiers
- Catalog Number
- 900480-US FDA UDI
- Primary DI / UDI-DI
- 08033860023461 EUDAMED08033860023225 EUDAMED08033860023249 EUDAMED08033860033071 EUDAMED08033860036799 EUDAMED08033860033057 EUDAMED08033860034719 EUDAMED08033860023423 EUDAMED08033860032975 EUDAMED08033860033019 EUDAMED08033860023324 EUDAMED08033860032739 EUDAMED08033860033118 EUDAMED08033860021771 EUDAMEDFDA UDI08033860023522 EUDAMED08033860023362 EUDAMED08033860034603 EUDAMED08033860033095 EUDAMED08033860033231 EUDAMED08033860033132 EUDAMED08033860032951 EUDAMED08033860023560 EUDAMED08033860032913 EUDAMED08033860023126 EUDAMED08033860034580 EUDAMED08033860032890 EUDAMED
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMED
- 510(k) Number
- K130616 FDA UDI
- FDA Product Code
- FCG FDA UDIKNW FDA UDI
- EMDN Code
- A0102010102 SHEARING BIOPSY GUNS EUDAMED
- GMDN Term
- Soft-tissue biopsy procedure kit, non-medicated FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 100 Millimeter FDA UDINeedle Gauge — 14 Gauge FDA UDI
Somacore Verify S 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (27)
- EUDAMED dc9a3776-86c1-41a3-b645-0b4784e97684 61 fields · synced Sep 18, 2026
- EUDAMED 8cdedff3-dc21-4255-b447-7d7b6cdb921c 61 fields · synced May 16, 2026
- EUDAMED 25277349-410f-4966-98f7-1b069ce4d649 61 fields · synced May 16, 2026
- EUDAMED d517e57b-155a-4207-9b9b-60b02a701dd0 61 fields · synced May 16, 2026
- EUDAMED 216d3ec3-7fd1-4f43-96b8-bbf43d688886 61 fields · synced May 17, 2026
- EUDAMED f6455f02-786d-47c1-b2c6-4da10df9da59 61 fields · synced May 17, 2026
- EUDAMED 22981a30-44f1-4c2e-9e8a-bf873e1a333e 61 fields · synced May 17, 2026
- EUDAMED ea8b947e-1318-4086-a51a-6f4d8339e334 61 fields · synced May 17, 2026
- EUDAMED 4c2adcdb-c41a-404b-aa3b-3332df043932 61 fields · synced May 18, 2026
- EUDAMED 41e5e1dd-b9c8-42bb-b248-968bab27bae6 61 fields · synced May 18, 2026
- EUDAMED 3fce4ae7-d6e0-4d8a-b6b0-da9b2a90cde8 61 fields · synced May 18, 2026
- EUDAMED 999e0962-e2bb-4797-9002-b6bcf6297f02 61 fields · synced May 18, 2026
- EUDAMED 1d4fb641-1f77-4b19-ac91-f5dd80fa7504 61 fields · synced May 18, 2026
- EUDAMED 56c7b596-d4fd-49cf-922e-fbeded065455 61 fields · synced May 18, 2026
- EUDAMED 6adddfd5-49fb-49dd-902c-b6fef7d0cb5b 61 fields · synced May 18, 2026
- EUDAMED 968f9062-1b4c-42a3-a905-52bf6fbdfa5d 61 fields · synced May 18, 2026
- EUDAMED ced8faa4-3c0d-46c5-ba9f-b8aa61ce547c 61 fields · synced May 18, 2026
- EUDAMED 01bd97c0-6e07-414f-9259-f7958e1e8182 61 fields · synced May 18, 2026
- EUDAMED aa6fe011-0158-4227-8bfe-636c9f45bb07 61 fields · synced May 18, 2026
- EUDAMED 7f4d6ed7-34d7-4e08-adbe-91fb5ca0275b 61 fields · synced May 18, 2026
- EUDAMED 9721f0e9-ebc5-40f4-ba22-c4d650cbc3f1 61 fields · synced May 18, 2026
- EUDAMED f73d9122-201e-4841-b7d5-36e4a6087fe7 61 fields · synced May 19, 2026
- EUDAMED a7c3302c-b072-4fdf-b454-5babac333d96 61 fields · synced May 19, 2026
- EUDAMED 812cf508-d7b8-4011-a37a-9d00db61c3fa 61 fields · synced May 19, 2026
- EUDAMED 28e05aef-fcaa-4d62-8a8d-914eabb94461 61 fields · synced May 19, 2026
- EUDAMED 7c8cb3ab-dcda-4ce8-8994-b88f0f00d75d 61 fields · synced May 19, 2026
- FDA UDI b289b74b-86e0-49fe-812a-711a42f1976a 37 fields · synced May 30, 2026