Selectra Extended Hook-55
EUDAMEDFDA UDIClass III (EU MDR)
Identity
- Trade Name
- Selectra Extended Hook-55 EUDAMEDFDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Model / Reference
- Selectra EUDAMED375528 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 375528 FDA UDI
- Primary DI / UDI-DI
- 04035479116729 EUDAMEDFDA UDI
- Basic UDI-DI
- 4035479BUDI00021PS EUDAMED
- FDA Product Code
- DQY FDA UDI
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Vascular catheter introduction set, nonimplantable
Selectra Extended Hook-55 by BIOTRONIK SE & Co. KG — Class III — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4035479BUDI00021PS | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- BIOTRONIK SE & Co. KG
- EUDAMED SRN
- DE-MF-000005049
Sources (2)
- EUDAMED 5571d78c-ba6f-491c-8c55-ae8ed37997cf 61 fields · synced Jul 10, 2026
- FDA UDI 262991b1-8fea-4c37-a6f5-7459b37f0e91 36 fields · synced May 30, 2026