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Speedband Superview Super 7™

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref M00542250

by Boston Scientific Corporation

Identity

Trade Name
Speedband Superview Super 7™ EUDAMED
Speedband Superview Super 7 FDA UDI
Generic Name
Oesophageal endoscopic ligator, single-use FDA UDI
Device Name
Speedband Superview Super 7 Band Ligator EUDAMED
Multiple Band Ligator FDA UDI
Model / Reference
M00542250 EUDAMEDFDA UDI
Description
Multiple Band Ligator FDA UDI

Identifiers

Primary DI / UDI-DI
08714729201953 EUDAMEDFDA UDI
Basic UDI-DI
01915060000000000000623NA EUDAMED
FDA Product Code
MND FDA UDI
FHN FDA UDI
EMDN Code
G03020301 LIGATURE SYSTEMS, OESOPHAGEAL VARICES EUDAMED
GMDN Term
Oesophageal endoscopic ligator, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
876.4400 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Speedband Superview Super 7™ by Boston Scientific Corporation — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Boston Scientific Corporation
EUDAMED SRN
US-MF-000004702
Authorised Representative
Boston Scientific Limited IE-AR-000003840

Sources (3)

  • EUDAMED 01c18cd0-addc-4696-9af2-bb2e0e644c8b 61 fields · synced Jul 12, 2026
  • FDA UDI 15a91836-f5b2-4dbd-b6e2-f1421a2bae9b 33 fields · synced May 30, 2026
  • FDA 510(k) K952262 1 fields · synced May 18, 2026