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BIOTRONIK Pulsar-18 T3 Peripheral Self Expanding Nitinol Stent System - HSA Registration DE0505163

Access comprehensive regulatory information for BIOTRONIK Pulsar-18 T3 Peripheral Self Expanding Nitinol Stent System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505163 and owned by Biotronik AG. The device was registered on November 20, 2020.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0505163
BIOTRONIK Pulsar-18 T3 Peripheral Self Expanding Nitinol Stent System
HSA Registration Number: DE0505163
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Product Description

Pulsar-18 T3 is indicated for use in patients with atherosclerotic disease of the superficial femoral, proximal popliteal and infrapopliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty (PTA), e.g. residual stenosis and dissection.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0505163
Registration Date
November 20, 2020
Change Notification Approval Date
April 22, 2025
Retention Due Date
November 19, 2025
Product Owner
Short Name
Biotronik
Address
Ackerstrasse 6, 8180 Bรผlach, SWITZERLAND
Registrant
Address
165 KALLANG WAY, #07-00, SINGAPORE 349257
Importer
Address
165 KALLANG WAY, #07-00, SINGAPORE 349257
Model Information
Model Name(s)
Pulsar-18 T3 4/20/90 Pulsar-18 T3 4/30/90 Pulsar-18 T3 4/40/90 Pulsar-18 T3 4/60/90 Pulsar-18 T3 4/80/90 Pulsar-18 T3 4/100/90 Pulsar-18 T3 4/120/90 Pulsar-18 T3 4/150/90 Pulsar-18 T3 4/170/90 Pulsar-18 T3 4/200/90 Pulsar-18 T3 5/20/90 Pulsar-18 T3 5/30/90 Pulsar-18 T3 5/40/90 Pulsar-18 T3 5/60/90 Pulsar-18 T3 5/80/90 Pulsar-18 T3 5/100/90 Pulsar-18 T3 5/120/90 Pulsar-18 T3 5/150/90 Pulsar-18 T3 5/170/90 Pulsar-18 T3 5/200/90 Pulsar-18 T3 6/20/90 Pulsar-18 T3 6/30/90 Pulsar-18 T3 6/40/90 Pulsar-18 T3 6/60/90 Pulsar-18 T3 6/80/90 Pulsar-18 T3 6/100/90 Pulsar-18 T3 6/120/90 Pulsar-18 T3 6/150/90 Pulsar-18 T3 6/170/90 Pulsar-18 T3 6/200/90 Pulsar-18 T3 7/20/90 Pulsar-18 T3 7/30/90 Pulsar-18 T3 7/40/90 Pulsar-18 T3 7/60/90 Pulsar-18 T3 7/80/90 Pulsar-18 T3 7/100/90 Pulsar-18 T3 7/120/90 Pulsar-18 T3 7/150/90 Pulsar-18 T3 7/170/90 Pulsar-18 T3 7/200/90 Pulsar-18 T3 4/20/135 Pulsar-18 T3 4/30/135 Pulsar-18 T3 4/40/135 Pulsar-18 T3 4/60/135 Pulsar-18 T3 4/80/135 Pulsar-18 T3 4/100/135 Pulsar-18 T3 4/120/135 Pulsar-18 T3 4/150/135 Pulsar-18 T3 4/170/135 Pulsar-18 T3 4/200/135 Pulsar-18 T3 5/20/135 Pulsar-18 T3 5/30/135 Pulsar-18 T3 5/40/135 Pulsar-18 T3 5/60/135 Pulsar-18 T3 5/80/135 Pulsar-18 T3 5/100/135 Pulsar-18 T3 5/120/135 Pulsar-18 T3 5/150/135 Pulsar-18 T3 5/170/135 Pulsar-18 T3 5/200/135 Pulsar-18 T3 6/20/135 Pulsar-18 T3 6/30/135 Pulsar-18 T3 6/40/135 Pulsar-18 T3 6/60/135 Pulsar-18 T3 6/80/135 Pulsar-18 T3 6/100/135 Pulsar-18 T3 6/120/135 Pulsar-18 T3 6/150/135 Pulsar-18 T3 6/170/135 Pulsar-18 T3 6/200/135 Pulsar-18 T3 7/20/135 Pulsar-18 T3 7/30/135 Pulsar-18 T3 7/40/135 Pulsar-18 T3 7/60/135 Pulsar-18 T3 7/80/135 Pulsar-18 T3 7/100/135 Pulsar-18 T3 7/120/135 Pulsar-18 T3 7/150/135 Pulsar-18 T3 7/170/135 Pulsar-18 T3 7/200/135
Model Identifier(s)
430437 430438 430439 430440 430441 430442 430443 430444 430445 430446 430447 430448 430449 430450 430451 430452 430453 430454 430455 430456 430457 430458 430459 430460 430461 430462 430463 430464 430465 430466 430467 430468 430469 430470 430471 430472 430473 430474 430475 430476 430477 430478 430479 430480 430481 430482 430483 430484 430485 430486 430487 430488 430489 430490 430491 430492 430493 430494 430495 430496 430497 430498 430499 430500 430501 430502 430503 430504 430505 430506 430507 430508 430509 430510 430511 430512 430513 430514 430515 430516