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Selectra Accessory Kit
EUDAMEDFDA UDIClass III (EU MDR)
Ref 375518Model Selectra
Identity
- Trade Name
- Selectra Accessory Kit EUDAMEDFDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Model / Reference
- Selectra EUDAMED375518 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 375518 FDA UDI
- Primary DI / UDI-DI
- 04035479116644 EUDAMEDFDA UDI
- Basic UDI-DI
- 4035479BUDI00021PS EUDAMED
- FDA Product Code
- DQY FDA UDI
- EMDN Code
- C058099 CARDIOCIRCULATORY SYSTEM INTRODUCERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Vascular catheter introduction set, nonimplantable 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Selectra Accessory Kit by BIOTRONIK SE & Co. KG — Class III — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 c1a7e2d6-7f1e-4718-8563-7a56600de653 61 fields · synced Jun 18, 2026
- FDA UDI 6993f8b9-0167-4a29-bac6-2a539e20b652 35 fields · synced May 30, 2026