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Calbreak
EUDAMEDClass III (EU MDR)
Ref 835768Ref 835520Ref 835766Ref 835519Ref 835529Ref 835549Ref 835767Ref 835526Ref 835528Ref 835764Ref 835532Ref 835531Ref 835770Ref 835769Ref 835530Ref 835524Ref 835534Ref 835525Ref 835553Ref 835762Ref 835537Ref 835550Ref 835551Ref 835535
Identity
- Trade Name
- Calbreak EUDAMED
- Device Name
- Coronary Cutting Balloon Dilatation Catheter EUDAMED
- Model / Reference
- 835768 EUDAMED835520 EUDAMED835766 EUDAMED835519 EUDAMED835529 EUDAMED835549 EUDAMED835767 EUDAMED835526 EUDAMED835528 EUDAMED835764 EUDAMED835532 EUDAMED835531 EUDAMED835770 EUDAMED835769 EUDAMED835530 EUDAMED835524 EUDAMED835534 EUDAMED835525 EUDAMED835553 EUDAMED835762 EUDAMED835537 EUDAMED835550 EUDAMED835551 EUDAMED835535 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251790257686 EUDAMED04251790255200 EUDAMED04251790257662 EUDAMED04251790255194 EUDAMED04251790255293 EUDAMED04251790255491 EUDAMED04251790257679 EUDAMED04251790255262 EUDAMED04251790255286 EUDAMED04251790257648 EUDAMED04251790255323 EUDAMED04251790255316 EUDAMED04251790257709 EUDAMED04251790257693 EUDAMED04251790255309 EUDAMED04251790255248 EUDAMED04251790255347 EUDAMED04251790255255 EUDAMED04251790255538 EUDAMED04251790257624 EUDAMED04251790255378 EUDAMED04251790255507 EUDAMED04251790255514 EUDAMED04251790255354 EUDAMED
- Basic UDI-DI
- 42517902VBCVE EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Coronary angioplasty balloon catheter, cutting/scoring
Calbreak by SWL Medizin GmbH — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Coronary angioplasty balloon catheter, cutting/scoring.
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- Pipit SC — Sahajanand Medical Technologies Limited · Class III
- POT — BrosMed Medical Co., Ltd. · Class III
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42517902VBCVE | Class III | Active |
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Manufacturer
- Manufacturer
- SWL Medizin GmbH
- EUDAMED SRN
- DE-MF-000008000
Sources (24)
- EUDAMED db81271f-ed7b-4484-b169-0581fabd2d38 61 fields · synced Oct 6, 2026
- EUDAMED d4b8d0f2-6f4c-49bb-80ce-b5a8bb7b42b6 61 fields · synced May 16, 2026
- EUDAMED 2a8c3ab9-498a-40af-b261-5bf4604bb321 61 fields · synced May 16, 2026
- EUDAMED 3c2f8bd2-5e3f-4d07-a16b-d559b68536fa 61 fields · synced May 17, 2026
- EUDAMED 4e4f2d40-0dbf-48e8-a0f5-4e989c18b6f1 61 fields · synced May 17, 2026
- EUDAMED 3e35c0d7-2136-4cfa-821b-e96dc5359c89 61 fields · synced May 17, 2026
- EUDAMED a0af0e02-8c46-4348-90ce-1b27f4e69dc5 61 fields · synced May 17, 2026
- EUDAMED 47e5a57c-5984-4865-9b18-ddcb39bf6474 61 fields · synced May 17, 2026
- EUDAMED 92d86130-7dd7-4d2c-8181-a4325e42877a 61 fields · synced May 17, 2026
- EUDAMED 3d0bf4cc-7ce2-44b4-8a30-c70d91030c18 61 fields · synced May 18, 2026
- EUDAMED 7fae64bd-ec20-4e1c-9cbf-7fcf8b19f737 61 fields · synced May 18, 2026
- EUDAMED b47d2903-29a2-4168-95af-766f9e852516 61 fields · synced May 18, 2026
- EUDAMED 937ef3a2-e980-4114-abca-d2a0d4cf0ae2 61 fields · synced May 18, 2026
- EUDAMED 147fd937-9cfb-4adb-a04e-b7f200146b74 61 fields · synced May 18, 2026
- EUDAMED a6ab91fc-66c3-4405-843a-92bce740ae10 61 fields · synced May 18, 2026
- EUDAMED 692f8737-1d2f-4809-96b3-66f9dd1d7c9e 61 fields · synced May 18, 2026
- EUDAMED ebf5c1d5-e915-45f3-bef5-a58fe6262cd9 61 fields · synced May 18, 2026
- EUDAMED 6bfa7e4b-aa7b-4e2a-9250-aad04b9e2451 61 fields · synced May 18, 2026
- EUDAMED 7041b82b-e32b-4966-a857-17931ce59d65 61 fields · synced May 18, 2026
- EUDAMED bca970e3-8053-4c60-804a-56e953603ce2 61 fields · synced May 18, 2026
- EUDAMED 1427781f-d254-4fe4-8e41-f34e868ea80f 61 fields · synced May 18, 2026
- EUDAMED ecf11578-709a-4dae-aaf2-b2a50e31ddfa 61 fields · synced May 18, 2026
- EUDAMED 3e0b5618-c663-4fa3-bc36-1e5d407609f5 61 fields · synced May 19, 2026
- EUDAMED 16aa12a1-9b65-44e1-a6e5-1751bd88087f 61 fields · synced May 19, 2026