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Speedybell Doppia Corsa

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref SBDST1815ECRef SBDTR1813ECRef SBDTRRN1410ECRef SBD2010ECRef SBDTRN1815ECTRef SB1615ECRef SBDTR1820ECRef SBDTR1615ECRef SBD1815ECRef SB1809ECRef SBD1610ECRef SBDTR1615ECTRef SBD1410ECRef SB1511ECRef SBD1825ECRef SBD1610ECTRef SB1609ECRef SB1415ECRef SBDTR1815ECTRef SBDTR1310ECRef SBD1615ECRef SBD1820ECRef SB1610ECRef SBDM1810ECRef SBM2115ECRef SB1815ECRef SB1811ECRef SBD1815ECTRef SBD1407ECTRef SBDST1410ECRef SBDTR1415ECTRef SBD2018ECRef SBDTRN1415ECTRef SBDTR2011ECRef SB1410Ref SBM1810ECRef SBDTR1410EC

by Biopsybell Srl

Identity

Trade Name
SPEEDYBELL DOPPIA CORSA EUDAMED
SPEEDYBELL DOPPIA CORSA & INTRODUTTORE EUDAMED
SPEEDYBELL EUDAMED
Biopsybell FDA UDI
Generic Name
End-cut biopsy gun handpiece/needle FDA UDI
Device Name
NEEDLES FOR BIOPSY OR EXPLANT EUDAMED
SPEEDYBELL DOPPIA CORSA EUDAMED
SPEEDYBELL EUDAMED
SOFT TISSUES BIOPSY NEEDLES (SEMIAUTOMATIC AND AUTOMATIC) EUDAMED
SPEEDYBELL DOPPIA CORSA & INTRODUTTORE EUDAMED
Semiautomatic guillotine needle for soft-tissue biopsy FDA UDI
Model / Reference
SBDST1815EC EUDAMED
SBDTR1813EC EUDAMED
SBDTRRN1410EC EUDAMED
SBD2010EC EUDAMED
SBDTRN1815ECT EUDAMED
SB1615EC EUDAMED
SBDTR1820EC EUDAMED
SBDTR1615EC EUDAMED
SBD1815EC EUDAMED
SB1809EC EUDAMED
SBD1610EC EUDAMED
SBDTR1615ECT EUDAMED
SBD1410EC EUDAMED
SB1511EC EUDAMED
SBD1825EC EUDAMED
SBD1610ECT EUDAMED
SB1609EC EUDAMED
SB1415EC EUDAMED
SBDTR1815ECT EUDAMED
SBDTR1310EC EUDAMED
SBD1615EC EUDAMED
SBD1820EC EUDAMED
SB1610EC EUDAMED
SBDM1810EC EUDAMED
SBM2115EC EUDAMED
SB1815EC EUDAMED
SB1811EC EUDAMED
SBD1815ECT EUDAMED
SBD1407ECT EUDAMED
SBDST1410EC EUDAMED
SBDTR1415ECT EUDAMED
SBD2018EC EUDAMED
SBDTRN1415ECT EUDAMED
SBDTR2011EC EUDAMED
SB1410 EUDAMED
SBM1810EC EUDAMED
SBDTR1410EC EUDAMED
SPEEDYBELL DOPPIA CORSA FDA UDI
SPEEDYBELL FDA UDI
SPEEDYBELL DOPPIA CORSA & INTRODUTTORE FDA UDI
Description
Semiautomatic guillotine needle for soft-tissue biopsy FDA UDI

Identifiers

Catalog Number
SBD1815EC FDA UDI
SBD1615EC FDA UDI
SB1415EC FDA UDI
SB1615EC FDA UDI
SBDTR1820EC FDA UDI
SBD1610EC FDA UDI
SB1815EC FDA UDI
SB1610EC FDA UDI
SBD1410EC FDA UDI
SBDTR1813EC FDA UDI
SBDTR1615EC FDA UDI
SBD1825EC FDA UDI
SBD2010EC FDA UDI
SBD1820EC FDA UDI
SBDTR1410EC FDA UDI
Primary DI / UDI-DI
08033860017248 EUDAMED
08033860011055 EUDAMEDFDA UDI
08033860012496 EUDAMED
08033860006518 EUDAMEDFDA UDI
08033860041380 EUDAMED
08033860000103 EUDAMEDFDA UDI
08033860008796 EUDAMEDFDA UDI
08033860011291 EUDAMEDFDA UDI
08033860004316 EUDAMEDFDA UDI
08033860012779 EUDAMED
08033860004439 EUDAMEDFDA UDI
08033860040086 EUDAMED
08033860004019 EUDAMEDFDA UDI
08033860020545 EUDAMED
08033860011956 EUDAMEDFDA UDI
08033860011017 EUDAMED
08033860000424 EUDAMED
08033860000127 EUDAMEDFDA UDI
08033860038458 EUDAMED
08033860013684 EUDAMED
08033860004392 EUDAMEDFDA UDI
08033860004279 EUDAMEDFDA UDI
08033860000080 EUDAMEDFDA UDI
08033860011659 EUDAMED
08033860014698 EUDAMED
08033860000547 EUDAMEDFDA UDI
08033860000486 EUDAMED
08033860015916 EUDAMED
08033860007911 EUDAMED
08033860017200 EUDAMED
08033860038304 EUDAMED
08033860014292 EUDAMED
08033860044442 EUDAMED
08033860023942 EUDAMED
08033860000561 EUDAMED
08033860003791 EUDAMED
08033860011277 EUDAMEDFDA UDI
Basic UDI-DI
8033860BIOEFT01U5 EUDAMED
B-08033860004439 EUDAMED
B-08033860000127 EUDAMED
B-08033860004392 EUDAMED
B-08033860000080 EUDAMED
B-08033860011956 EUDAMED
B-08033860006518 EUDAMED
B-08033860004019 EUDAMED
B-08033860000424 EUDAMED
B-08033860000547 EUDAMED
B-08033860004279 EUDAMED
B-08033860000103 EUDAMED
B-08033860004316 EUDAMED
8033860BIOAFT01SR EUDAMED
B-08033860011277 EUDAMED
B-08033860011291 EUDAMED
B-08033860008796 EUDAMED
B-08033860011055 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
Needle Gauge — 18 Gauge FDA UDI
Length — 150 Millimeter FDA UDI
Needle Gauge — 16 Gauge FDA UDI
Needle Gauge — 14 Gauge FDA UDI
Length — 200 Millimeter FDA UDI
Length — 100 Millimeter FDA UDI
Length — 130 Millimeter FDA UDI
Length — 250 Millimeter FDA UDI
Needle Gauge — 20 Gauge FDA UDI

Speedybell Doppia Corsa 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 (85)

  • EUDAMED 642f627a-3be0-4f86-b9af-a03cf43db106 61 fields · synced Oct 1, 2026
  • EUDAMED 19046ba3-882b-410b-bc01-1a89687704ac 61 fields · synced May 11, 2026
  • EUDAMED f24f497b-3234-4b43-82fa-f1ef94439d74 61 fields · synced May 16, 2026
  • EUDAMED 26a89032-21b0-4ad9-9b7d-6acdcdede981 61 fields · synced May 16, 2026
  • EUDAMED a63d1ff5-f8c2-4c9d-928c-602f71492038 61 fields · synced May 16, 2026
  • EUDAMED 00d587b1-1519-4a42-8313-2a4cb4f1bd0a 61 fields · synced May 16, 2026
  • EUDAMED 284b79ea-f9fe-41bf-9042-dadd69164c80 61 fields · synced May 16, 2026
  • EUDAMED d7414e5c-467e-4902-b827-6ff1e68355c2 61 fields · synced May 16, 2026
  • EUDAMED 94583001-03bd-49d3-859f-ca1f82711528 61 fields · synced May 16, 2026
  • EUDAMED f2befd3c-2a17-4852-8d23-d77ed9ab985a 61 fields · synced May 17, 2026
  • EUDAMED f436f3b6-729a-4c5e-bf74-2217d8b1f610 61 fields · synced May 17, 2026
  • EUDAMED 01eff296-1dde-498d-88da-7bd1a6afbad1 61 fields · synced May 17, 2026
  • EUDAMED 1b911a3b-9f03-4908-b114-4e719b7f0e87 61 fields · synced May 17, 2026
  • EUDAMED 9b0847cc-22f9-4ae0-ade3-b71001b068b6 61 fields · synced May 17, 2026
  • EUDAMED d5460bc5-9e62-424c-8b64-d970771d1b2a 61 fields · synced May 17, 2026
  • EUDAMED 7b52bd55-934f-4f25-b55c-82bbd930eb27 61 fields · synced May 17, 2026
  • EUDAMED 9dfe8c2e-11ea-47e1-ab55-968153e5aeb1 61 fields · synced May 17, 2026
  • EUDAMED d8190428-e504-4a46-99e9-b903f9a1fc90 61 fields · synced May 17, 2026
  • EUDAMED 06a915d9-31fc-49d6-8945-404a62d738de 61 fields · synced May 18, 2026
  • EUDAMED 407bfce0-28cf-48f7-953a-76a5cf4cfe30 61 fields · synced May 18, 2026
  • EUDAMED 38eb0ff6-dfe1-4dc2-adf7-c0164c1aaad4 61 fields · synced May 18, 2026
  • EUDAMED 7b7f8beb-5dde-448f-ab32-b37d84ff7e93 61 fields · synced May 18, 2026
  • EUDAMED 615a690c-c39d-493b-b232-78feaa0ef3df 61 fields · synced May 18, 2026
  • EUDAMED 680bfe19-2fa9-43b3-a365-e94268479f0d 61 fields · synced May 18, 2026
  • EUDAMED 36b55fa4-42c1-4345-ba40-8b841c7e28bc 61 fields · synced May 18, 2026
  • EUDAMED fa85265f-2977-4b7e-8bc4-acea712f92a9 61 fields · synced May 18, 2026
  • EUDAMED 54d543d6-c210-4b00-9ac1-4d6d3d81a9b6 61 fields · synced May 18, 2026
  • EUDAMED 5820f3aa-635d-46eb-9c3d-271f5148fe19 61 fields · synced May 18, 2026
  • EUDAMED b33bf0ab-0be3-497f-af19-4570ef0c857c 61 fields · synced May 18, 2026
  • EUDAMED 93ca18cd-101a-4987-90c1-195b4933888e 61 fields · synced May 18, 2026
  • EUDAMED 55e9f4e8-c578-46a2-b8a0-f3ff764e9eda 61 fields · synced May 18, 2026
  • EUDAMED ab027147-be5d-447d-bc97-44f75f6235b7 61 fields · synced May 18, 2026
  • EUDAMED 8346cfef-9836-4301-92c2-13972923c22a 61 fields · synced May 18, 2026
  • EUDAMED f9254b9e-fab6-4288-a67f-b8778b9b13ec 61 fields · synced May 18, 2026
  • EUDAMED e49ea886-0b1e-4234-a44e-30f1c8e62fd5 61 fields · synced May 18, 2026
  • EUDAMED 19b863cd-3dbb-4938-8788-ad0c4ccc74e5 61 fields · synced May 18, 2026
  • EUDAMED 0c317020-a7e4-4df2-8f9e-adab9079c577 61 fields · synced May 19, 2026
  • EUDAMED 2da0653e-9e73-4e24-a205-b1df9c1455dc 61 fields · synced May 19, 2026
  • EUDAMED 70316125-0091-4e4d-b032-12c270cca104 61 fields · synced May 19, 2026
  • EUDAMED bf2d912f-443e-454f-91c9-b5007211e86e 61 fields · synced May 19, 2026
  • EUDAMED acdcbadc-b20a-41f0-b641-85624202e315 61 fields · synced May 19, 2026
  • EUDAMED de91d90e-08eb-4028-b59f-4469eef6b60e 61 fields · synced May 19, 2026
  • EUDAMED 1074225b-a293-4645-bcfa-9ab4b6a87d69 61 fields · synced May 19, 2026
  • EUDAMED 0d9ccb59-1825-4db4-8cf8-7adfcc9443d6 61 fields · synced May 19, 2026
  • EUDAMED fbedea64-d9d8-4e6c-96c4-61f5800aed96 61 fields · synced May 19, 2026
  • EUDAMED 386bbb61-ab3e-4eaf-ba2b-7cf01064e961 61 fields · synced May 19, 2026
  • EUDAMED 7c7a1824-8c93-44bd-a929-eada59cbb396 61 fields · synced May 19, 2026
  • EUDAMED 76a8ddcf-e19e-4c87-a14d-9cb2bc4e8bcb 61 fields · synced May 19, 2026
  • EUDAMED 6ecd4bf2-45bf-4a2f-9e78-5deeaa374b90 61 fields · synced May 19, 2026
  • FDA UDI e1209435-c421-4a16-bc5d-f913d3ef5794 37 fields · synced May 29, 2026
  • FDA UDI 61f5af6a-2796-4e50-a895-9b13b675e507 37 fields · synced May 29, 2026
  • FDA UDI 4aa3eff8-6ac8-49e5-9fd6-f36380fdddb8 37 fields · synced May 29, 2026
  • FDA UDI aaa27677-0316-47d9-b960-522a10aa6d1c 37 fields · synced May 30, 2026
  • FDA UDI c6d2e4a0-0587-46e3-bbd7-15c68c46f76f 37 fields · synced May 30, 2026
  • FDA UDI 06108b95-4ed2-4a94-9ff9-643dca0fce96 37 fields · synced May 30, 2026
  • FDA UDI 4f8e6dde-f47f-4135-a53c-5a53ccd2e5d6 37 fields · synced May 30, 2026
  • FDA UDI 5a1a6227-7cdd-4431-83b5-2b2ad62f53fd 37 fields · synced May 30, 2026
  • FDA UDI 5e79e86f-2d06-4196-9ef6-562411374917 37 fields · synced May 30, 2026
  • FDA UDI 8b6a23bb-7d2c-40bd-8699-c536ddd6aea2 37 fields · synced May 30, 2026
  • FDA UDI 303d6323-8dac-4c39-b8a9-861c3e049799 37 fields · synced May 30, 2026
  • FDA UDI 824625f7-a2b5-4189-856d-7e2a44393175 37 fields · synced May 30, 2026
  • FDA UDI c437b9a5-5f63-45ff-99a4-da02edefdb5d 37 fields · synced May 30, 2026
  • FDA UDI ca985f16-aebd-4e67-9e99-a944bdf860d0 37 fields · synced May 30, 2026
  • FDA UDI 2db3a9d0-c105-4cbc-b371-f1bb09bd7c3f 37 fields · synced May 30, 2026
  • EUDAMED b903f9bf-5e63-436e-badd-b8920e75cf80 61 fields · synced Jun 18, 2026
  • EUDAMED 4199bef0-12b6-49af-900b-a4ce49c43dc2 61 fields · synced Jun 19, 2026
  • EUDAMED 962d3985-b254-4dc0-beee-91ed5bc76014 61 fields · synced Jul 8, 2026
  • EUDAMED f3696c8f-3ba8-4eb2-8347-fe17c19f3c84 61 fields · synced Jul 8, 2026
  • EUDAMED 175959ec-36e5-48a7-80b7-a2043a24d44e 61 fields · synced Jul 9, 2026
  • EUDAMED 1414974e-abb8-44db-8be7-fabdd9c53f22 61 fields · synced Jul 9, 2026
  • EUDAMED 482156ba-0819-4f2d-9492-67c644c2103c 61 fields · synced Jul 9, 2026
  • EUDAMED f57143f9-70f4-44cd-b2f1-8b51c5241e7d 61 fields · synced Jul 9, 2026
  • EUDAMED 126e3247-6d11-4ce9-86f2-2f641c97513e 61 fields · synced Jul 9, 2026
  • EUDAMED b90c686d-ce6e-4d44-98fb-60ddc457739e 61 fields · synced Jul 10, 2026
  • EUDAMED 7d9e9b6d-802b-43d4-a700-fec997dcab8a 61 fields · synced Jul 15, 2026
  • EUDAMED ba974c7a-6a95-40aa-ae01-d830e3d2c055 61 fields · synced Jul 15, 2026
  • EUDAMED 4c231b4c-8f44-4277-b8c3-6ecfd3f5779d 61 fields · synced Jul 21, 2026
  • EUDAMED 90659d2a-fded-478e-8035-f79a187d00b5 61 fields · synced Jul 26, 2026
  • EUDAMED f29bc098-1399-4099-be47-04a650c83ccd 61 fields · synced Jul 29, 2026
  • EUDAMED 83262d71-6455-436f-b328-f865ce0f6bcf 61 fields · synced Jul 29, 2026
  • EUDAMED cfa81769-4931-4d18-96cf-4060349ad898 61 fields · synced Jul 29, 2026
  • EUDAMED e5f812a6-6683-4810-84e0-fdcf52e4e9e3 61 fields · synced Jul 30, 2026
  • EUDAMED 9f55de1a-e598-463a-84d7-6b70edaf1457 61 fields · synced Jul 30, 2026
  • EUDAMED 0e6589b9-a86c-4b24-af68-5b4409620bfd 61 fields · synced Jul 31, 2026
  • EUDAMED bb7ef8b1-55e9-49bc-bd91-96dc630d7724 61 fields · synced Oct 1, 2026