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Speedybell & Introduttore

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref SBTR2125ECRef SBTR1613ECRef SBTR1407ECRef SBTR1410ECRef SBMTR1810ECRef SBTR1825ECRef SBTR1420ECRef SBMTR2015ECRef SBTR1615ECRef SBTR1620ECRef SBTR1820ECRef SBTRRN1410ECRef SBTR1610ECRef SBTR1412ECRef SBTR1820ECTRef SBTR2010ECRef SBTR2020ECRef SBTR1415ECRef SBTR2015ECRef SBTR1815ECRef SBTR1409ECRef SBTR1920ECRef SBTR1810ECRef SBMTR2120ECRef SBTR1811EC

by Biopsybell Srl

Identity

Trade Name
SPEEDYBELL & INTRODUTTORE EUDAMED
Biopsybell FDA UDI
Generic Name
End-cut biopsy gun handpiece/needle FDA UDI
Device Name
NEEDLES FOR BIOPSY OR EXPLANT EUDAMED
SPEEDYBELL & INTRODUTTORE EUDAMED
SOFT TISSUES BIOPSY NEEDLES (SEMIAUTOMATIC AND AUTOMATIC) EUDAMED
Semiautomatic guillotine needle for soft-tissue biopsy FDA UDI
Model / Reference
SBTR2125EC EUDAMED
SBTR1613EC EUDAMED
SBTR1407EC EUDAMED
SBTR1410EC EUDAMED
SBMTR1810EC EUDAMED
SBTR1825EC EUDAMED
SBTR1420EC EUDAMED
SBMTR2015EC EUDAMED
SBTR1615EC EUDAMED
SBTR1620EC EUDAMED
SBTR1820EC EUDAMED
SBTRRN1410EC EUDAMED
SBTR1610EC EUDAMED
SBTR1412EC EUDAMED
SBTR1820ECT EUDAMED
SBTR2010EC EUDAMED
SBTR2020EC EUDAMED
SBTR1415EC EUDAMED
SBTR2015EC EUDAMED
SBTR1815EC EUDAMED
SBTR1409EC EUDAMED
SBTR1920EC EUDAMED
SBTR1810EC EUDAMED
SBMTR2120EC EUDAMED
SBTR1811EC EUDAMED
SPEEDYBELL & INTRODUTTORE FDA UDI
Description
Semiautomatic guillotine needle for soft-tissue biopsy FDA UDI

Identifiers

Catalog Number
SBTR1420EC FDA UDI
SBTR1620EC FDA UDI
SBTR1820EC FDA UDI
SBTR1825EC FDA UDI
SBTR1613EC FDA UDI
SBTR1407EC FDA UDI
SBTR2020EC FDA UDI
SBTR1815EC FDA UDI
SBTR1810EC FDA UDI
SBTR2010EC FDA UDI
SBTR1610EC FDA UDI
SBTR1920EC FDA UDI
SBTR2015EC FDA UDI
SBTR1410EC FDA UDI
SBTR1615EC FDA UDI
SBTR1415EC FDA UDI
SBTR2125EC FDA UDI
Primary DI / UDI-DI
08033860013912 EUDAMEDFDA UDI
08033860012557 EUDAMEDFDA UDI
08033860014575 EUDAMEDFDA UDI
08033860003500 EUDAMEDFDA UDI
08033860003753 EUDAMED
08033860006433 EUDAMEDFDA UDI
08033860026882 EUDAMEDFDA UDI
08033860020941 EUDAMED
08033860012236 EUDAMEDFDA UDI
08033860013387 EUDAMEDFDA UDI
08033860006396 EUDAMEDFDA UDI
08033860003388 EUDAMED
08033860002909 EUDAMEDFDA UDI
08033860010614 EUDAMED
08033860013622 EUDAMED
08033860003203 EUDAMEDFDA UDI
08033860011536 EUDAMEDFDA UDI
08033860002961 EUDAMEDFDA UDI
08033860003401 EUDAMEDFDA UDI
08033860005276 EUDAMEDFDA UDI
08033860011253 EUDAMED
08033860017163 EUDAMEDFDA UDI
08033860003777 EUDAMEDFDA UDI
08033860005634 EUDAMED
08033860008277 EUDAMED
Basic UDI-DI
8033860BIOEFT01U5 EUDAMED
B-08033860003500 EUDAMED
B-08033860006433 EUDAMED
B-08033860026882 EUDAMED
B-08033860013387 EUDAMED
B-08033860006396 EUDAMED
B-08033860012557 EUDAMED
B-08033860003388 EUDAMED
B-08033860003203 EUDAMED
B-08033860011536 EUDAMED
B-08033860002961 EUDAMED
B-08033860003401 EUDAMED
B-08033860014575 EUDAMED
B-08033860017163 EUDAMED
B-08033860003777 EUDAMED
B-08033860005276 EUDAMED
B-08033860012236 EUDAMED
B-08033860002909 EUDAMED
8033860BIOAFT01SR EUDAMED
B-08033860013912 EUDAMED
510(k) Number
K130616 FDA UDI
FDA Product Code
FCG FDA UDI
KNW FDA UDI
EMDN Code
A0102010101 SHEARING BIOPSY NEEDLES EUDAMED
GMDN Term
End-cut biopsy gun handpiece/needle FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class 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 — 200 Millimeter FDA UDI
Needle Gauge — 14 Gauge FDA UDI
Needle Gauge — 16 Gauge FDA UDI
Needle Gauge — 18 Gauge FDA UDI
Length — 250 Millimeter FDA UDI
Length — 130 Millimeter FDA UDI
Length — 70 Millimeter FDA UDI
Needle Gauge — 20 Gauge FDA UDI
Length — 150 Millimeter FDA UDI
Length — 100 Millimeter FDA UDI
Needle Gauge — 19 Gauge FDA UDI
Needle Gauge — 21 Gauge FDA UDI

Speedybell & 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biopsybell Srl
EUDAMED SRN
IT-MF-000011601

Sources (90)

  • EUDAMED 951d48f6-6b73-4161-9383-dd2e9a3360e2 61 fields · synced Sep 17, 2026
  • EUDAMED b0037e98-7a44-49d2-a862-38e5974f6326 61 fields · synced May 11, 2026
  • EUDAMED 75862f39-ab5f-4627-9ed8-81eab442f821 61 fields · synced May 16, 2026
  • EUDAMED 0c176c4d-781d-4288-bb36-65826b149954 61 fields · synced May 16, 2026
  • EUDAMED 3389b3e1-1546-4dff-b798-73381ab328f1 61 fields · synced May 16, 2026
  • EUDAMED 1bf22319-5328-4537-8242-1b352a246eb1 61 fields · synced May 16, 2026
  • EUDAMED 64c019fe-08a2-4351-8c89-3c91ac89103c 61 fields · synced May 16, 2026
  • EUDAMED 24bfb3f8-9ea5-4fdf-a238-58b73c6afa04 61 fields · synced May 17, 2026
  • EUDAMED 48248e51-4d33-4133-a839-f1cc28f9f263 61 fields · synced May 17, 2026
  • EUDAMED 288267f6-6de6-4f2f-a09a-fd17fdf2a5fb 61 fields · synced May 17, 2026
  • EUDAMED 231527cf-2eee-454f-bcb3-e7efa18fdc56 61 fields · synced May 17, 2026
  • EUDAMED 59f9269a-3992-431e-b1bd-9667c13c7351 61 fields · synced May 17, 2026
  • EUDAMED ac396188-b029-4699-9be1-f41d75427413 61 fields · synced May 17, 2026
  • EUDAMED 23297d80-09d0-494e-b654-ef2cf21084cd 61 fields · synced May 18, 2026
  • EUDAMED 4aa13627-0cd2-42ad-8df8-71cda96d1f49 61 fields · synced May 18, 2026
  • EUDAMED a97f1575-23b7-40d7-a007-9bde114e5525 61 fields · synced May 18, 2026
  • EUDAMED 24a6e931-071d-42ad-b41b-8639924bd4b0 61 fields · synced May 18, 2026
  • EUDAMED 6178d862-41da-49d6-8365-d174ac61a58a 61 fields · synced May 18, 2026
  • EUDAMED 65065060-139b-4ffd-a0e5-1acf9d3c77c2 61 fields · synced May 18, 2026
  • EUDAMED b330f719-ce41-4843-9f0e-7cc58e24488c 61 fields · synced May 18, 2026
  • EUDAMED 3d78d061-d8f9-4bb8-9224-de323e6b9159 61 fields · synced May 18, 2026
  • EUDAMED 387efe27-ae78-4926-85ba-1edb359d5ed3 61 fields · synced May 18, 2026
  • EUDAMED a2d36b7c-4168-4a7b-a222-647043d58583 61 fields · synced May 18, 2026
  • EUDAMED 30b0f64a-66c2-43a2-b4c3-35321bb812f8 61 fields · synced May 18, 2026
  • EUDAMED 39b1d812-48e6-4928-8f8e-c64fcbd336a1 61 fields · synced May 18, 2026
  • EUDAMED b423470a-29ea-4501-9c25-599e4dfbf6e5 61 fields · synced May 18, 2026
  • EUDAMED c01016e3-16b1-4946-b724-9fb04d3a3a13 61 fields · synced May 18, 2026
  • EUDAMED 7810e9b1-6363-4027-afff-44345da3a912 61 fields · synced May 18, 2026
  • EUDAMED e4a23c8a-26bc-489f-a14b-ba59e196fd89 61 fields · synced May 18, 2026
  • EUDAMED 5827ba23-5fd1-48f6-b51f-27c46ec8ca12 61 fields · synced May 19, 2026
  • EUDAMED 8dd7b588-7fca-4fc2-92ef-9e3572a24ea6 61 fields · synced May 19, 2026
  • EUDAMED 7bac1826-28f7-4475-89a9-3d9a7371232b 61 fields · synced May 19, 2026
  • EUDAMED 23144a95-282b-40d4-9c22-4d13d44f65fc 61 fields · synced May 19, 2026
  • EUDAMED 5ace377c-7a3f-403b-bcfc-42d46f7c870a 61 fields · synced May 19, 2026
  • EUDAMED 5ddd2962-c491-4555-a838-dd9d6a9fe37f 61 fields · synced May 19, 2026
  • EUDAMED 4aa7bf9d-6054-41dd-a0be-6abb5141a134 61 fields · synced May 19, 2026
  • EUDAMED 50bdfd11-6b76-4f2e-906f-5161f750fa82 61 fields · synced May 19, 2026
  • EUDAMED 45ec5405-307c-442d-a14b-eacedb1b8b8e 61 fields · synced May 19, 2026
  • EUDAMED 0821ceda-a00a-4ac9-81e5-0577eb77add7 61 fields · synced May 19, 2026
  • EUDAMED a2ff21a4-eb35-40ca-bacf-1280f12dfd9d 61 fields · synced May 19, 2026
  • EUDAMED 327f7685-f012-4136-81e4-b53c8ce3855e 61 fields · synced May 19, 2026
  • EUDAMED 4d751d88-cf1d-4966-bfe6-8c37e2c1aadd 61 fields · synced May 19, 2026
  • FDA UDI d92628df-ab1c-4f2d-86f2-c25a83390ad5 37 fields · synced May 29, 2026
  • FDA UDI 85e5106e-f564-4482-b57f-faf70c17a20a 37 fields · synced May 29, 2026
  • FDA UDI a832284a-05e6-4535-8cfd-c2285a0a5f49 37 fields · synced May 30, 2026
  • FDA UDI 5d0b5c55-cc9b-4639-aba4-04ac80849602 37 fields · synced May 30, 2026
  • FDA UDI 24acca70-ca0e-4fc2-9ca3-36ddcda16025 37 fields · synced May 30, 2026
  • FDA UDI 6eecf26d-7595-46cd-8bd2-1e4ffeea2b1e 37 fields · synced May 30, 2026
  • FDA UDI 3c07ee97-2e7e-48bd-b7c1-5925914c5ad6 37 fields · synced May 30, 2026
  • FDA UDI 1c612c32-9528-4f92-ba23-f043c26a3877 37 fields · synced May 30, 2026
  • FDA UDI fe5d0737-b011-408b-8804-ccba0083e9f5 37 fields · synced May 30, 2026
  • FDA UDI 68888dc4-0ee7-428f-9cf9-371170bdc648 37 fields · synced May 30, 2026
  • FDA UDI c3ce1ec4-544a-4bdb-b0f9-92514e028fc9 37 fields · synced May 30, 2026
  • FDA UDI 8d3ef483-a30a-41ac-b06a-eeaf3c019f51 37 fields · synced May 30, 2026
  • FDA UDI 07842782-a9c3-49cf-ae4c-bf543e34e1fd 37 fields · synced May 30, 2026
  • FDA UDI 0c6f5fef-315b-46db-a10f-7e4810b51dd8 37 fields · synced May 30, 2026
  • FDA UDI 06ca64fd-6da3-4ba5-8911-3638a0c04484 37 fields · synced May 30, 2026
  • FDA UDI ed85cef3-65e2-4092-b79f-005cdcb31290 37 fields · synced May 30, 2026
  • FDA UDI 0779a7ac-05bd-4e72-af44-5912afb3929b 37 fields · synced May 30, 2026
  • EUDAMED 78ad14ea-3fe5-4896-86b3-1833edfca89d 61 fields · synced Jun 11, 2026
  • EUDAMED b7eeef28-9767-4c58-b527-e40b08b7056c 61 fields · synced Jun 11, 2026
  • EUDAMED 29876ed4-6a09-4926-8e9f-b25825b977e7 61 fields · synced Jun 14, 2026
  • EUDAMED eb4e73b9-2d4c-42f1-a0a9-5a569ce53825 61 fields · synced Jun 18, 2026
  • EUDAMED 58e5b18f-5e94-4cf6-9ec8-e491f94ea510 61 fields · synced Jun 18, 2026
  • EUDAMED 2551e951-de5f-4016-a32b-e294a6daf258 61 fields · synced Jun 18, 2026
  • EUDAMED 8540870b-0e6b-4a7d-8baa-d6df3c14aae9 61 fields · synced Jun 19, 2026
  • EUDAMED 21dcf01c-3104-4c8c-be12-8fbc114d2a48 61 fields · synced Jun 19, 2026
  • EUDAMED 3574a47b-4087-41fe-ac5a-3ed34ffb27b7 61 fields · synced Jul 9, 2026
  • EUDAMED f844bca8-1886-4fcd-b4c9-5ad4c08cb78f 61 fields · synced Jul 9, 2026
  • EUDAMED cde5aa73-e2a8-46d6-880c-7e0f5fe9b372 61 fields · synced Jul 9, 2026
  • EUDAMED 95231e37-02a5-456a-96f4-cd3c3eaafafb 61 fields · synced Jul 10, 2026
  • EUDAMED 66547353-e450-4921-9a87-f257d23c2fd2 61 fields · synced Jul 11, 2026
  • EUDAMED e49cf30d-4b06-4306-a5e9-50a910a60e83 61 fields · synced Jul 11, 2026
  • EUDAMED 7d92b52a-8e79-483b-a3c4-7e0b73ae7dda 61 fields · synced Jul 12, 2026
  • EUDAMED c5a722a2-7ed8-4bca-a309-b742fcb42041 61 fields · synced Jul 12, 2026
  • EUDAMED 1882fce6-8b76-4abc-be62-093ec103223f 61 fields · synced Jul 13, 2026
  • EUDAMED 899af5c1-fc51-484a-99c0-0b8d5ab34c2d 61 fields · synced Jul 14, 2026
  • EUDAMED 3da1e46a-2922-4326-ae8f-8edeca3d6953 61 fields · synced Jul 15, 2026
  • EUDAMED 3aa6d9a3-92a3-4f7b-930d-42f1c75baf1e 61 fields · synced Jul 15, 2026
  • EUDAMED 4171cce9-0863-4d58-9fbb-830c264920d6 61 fields · synced Jul 16, 2026
  • EUDAMED ba345778-055d-4329-9af4-f0899425f6e6 61 fields · synced Jul 18, 2026
  • EUDAMED 1c237c24-ca6e-46ef-a206-2cad8c7d4077 61 fields · synced Jul 19, 2026
  • EUDAMED bb853c2a-40bc-4f54-8351-c0b0c48be2aa 61 fields · synced Jul 19, 2026
  • EUDAMED b62c7979-0c46-40d2-8c4c-ab410f5dae4a 61 fields · synced Jul 22, 2026
  • EUDAMED 4642d4d5-4c55-4a40-b525-601e82e62946 61 fields · synced Jul 22, 2026
  • EUDAMED b8c1974d-2e29-4703-83a9-1e33481cb576 61 fields · synced Jul 26, 2026
  • EUDAMED de05fe03-7c30-4def-bccc-b9c27ca7a42a 61 fields · synced Jul 27, 2026
  • EUDAMED a9dfcb8a-9fa6-4290-b270-7db504ce9332 61 fields · synced Aug 1, 2026
  • EUDAMED a53016e7-47aa-49b4-b94e-07d544407f92 61 fields · synced Aug 4, 2026
  • EUDAMED 7b326606-ec29-4b5a-8607-52e9b8a0c937 61 fields · synced Sep 17, 2026