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Introducer Sheath Kit
EUDAMEDClass IIa (EU MDR)
Ref AFIS 5F-11-038Ref ATIS 7F-07-025Ref AFIS 9F-11-038Ref ATIS 5F-07-025Ref ATIS 6F-07-025Ref AFIS 4F-09-021Ref ARIS 6F-07-025Ref AFIS 8F-11-038
Identity
- Trade Name
- Introducer Sheath Kit EUDAMED
- Device Name
- AD-DUCER Introducer Sheath Kit EUDAMED
- Model / Reference
- AFIS 5F-11-038 EUDAMEDATIS 7F-07-025 EUDAMEDAFIS 9F-11-038 EUDAMEDATIS 5F-07-025 EUDAMEDATIS 6F-07-025 EUDAMEDAFIS 4F-09-021 EUDAMEDARIS 6F-07-025 EUDAMEDAFIS 8F-11-038 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904314400961 EUDAMED18904314401098 EUDAMED18904314401005 EUDAMED18904314401074 EUDAMED18904314401081 EUDAMED18904314400954 EUDAMED18904314401043 EUDAMED18904314400992 EUDAMED
- Basic UDI-DI
- B-18904314400961 EUDAMEDB-18904314401098 EUDAMEDB-18904314401005 EUDAMEDB-18904314401074 EUDAMEDB-18904314401081 EUDAMEDB-18904314400954 EUDAMEDB-18904314401043 EUDAMEDB-18904314400992 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-18904314400961 | 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 (8)
- EUDAMED e9892fbf-bc80-4fac-a8ea-a3df42f6ee4d 61 fields · synced Aug 4, 2026
- EUDAMED 2b568d18-62de-4312-85a9-835bdb597ac8 61 fields · synced May 17, 2026
- EUDAMED f2928bb3-9f47-406f-8db4-bf07bbb1738b 61 fields · synced May 17, 2026
- EUDAMED a55a64c6-ee9e-4782-9561-4cde4a7aff0a 61 fields · synced May 17, 2026
- EUDAMED 0b010b7d-fc66-4e87-a0c8-54e27888bba0 61 fields · synced May 17, 2026
- EUDAMED 30dc0290-92a5-44c3-bbd3-b09ca11f2e5c 61 fields · synced May 18, 2026
- EUDAMED 1f664946-2b66-436f-b63e-c439e202bb8f 61 fields · synced May 18, 2026
- EUDAMED 2c730103-f9a7-4290-9cfa-7d0397f8d06b 61 fields · synced May 18, 2026