Vesscrack
by Lepu Medical Technology (Beijing) Co., Ltd. 9 variants
Part of a family of 9 devices: see the family page
Ref 4.00×12
Vesscrack (4.00×12) is a Class III device made by Lepu Medical Technology (Beijing) Co., Ltd., registered in EUDAMED on 10 Jun 2026 (Basic UDI-DI 69367337LP0042MN) with CE/MDR certificate MDR 818410 valid until 19 Jan 2031, active as of 24 Oct 2026.
Active
CE MDR
Valid until
19 Jan 2031
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69367337LP0042MN 06941785262228 | Date10 Jun 2026 | StatusActive |
Official records
- EUDAMED public site 69367337LP0042MN
Certificates
- MDR 818410 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 20 Jan 2026
- Expires
- 19 Jan 2031
Timeline
- Certificate issued EUDAMED MDR 818410
- Registered EUDAMED 69367337LP0042MN
- Certificate expires EUDAMED MDR 818410
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Coronary IVL Balloon Dilatation Catheter
- Model / reference
- 4.00×12
- Primary DI / UDI-DI
- 06941785262228
- Basic UDI-DI
- 69367337LP0042MN
- EMDN code
- C010401020199 Ptca dilatation catheters - other
- Device class
- Class III
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000001408
- Authorised representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
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Other devices from Lepu Medical Technology (Beijing) Co., Ltd.
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