Identity
- Trade Name
- Introducer Sheath Kit EUDAMED
- Device Name
- AD-DUCER Introducer Sheath Kit EUDAMED
- Model / Reference
- AFIS 7F-11-038 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904314400985 EUDAMED
- Basic UDI-DI
- B-18904314400985 EUDAMED
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Vascular catheter introduction set, nonimplantable
Introducer Sheath Kit by Advanced LifeSciences Pvt. Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Vascular catheter introduction set, nonimplantable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-18904314400985 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Advanced LifeSciences Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000016421
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED ae9206c4-469d-4e0f-a059-3f8cdd8fa80d 61 fields · synced Jun 18, 2026