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A. V. Fistula Sets for Hemodialysis
EUDAMEDClass IIa (EU MDR)
Ref AVFE1525CPLRGRef AVF1525CPLFGRef AVFE1520CPLRGRef AVFE1525CPLFGRef AVFE1525CLRGRef AVFE1525CLFGRef AVFE1725CLRGRef AVF1625CPLFGRef AVFE1720CPLRGRef AVFE1725CPLFGRef AVFE1625CPLFGRef AVFE1525CYFG
Identity
- Trade Name
- A. V. Fistula Sets for Hemodialysis EUDAMED
- Device Name
- A. V. Fistula Sets for Hemodialysis EUDAMED
- Model / Reference
- AVFE1525CPLRG EUDAMEDAVF1525CPLFG EUDAMEDAVFE1520CPLRG EUDAMEDAVFE1525CPLFG EUDAMEDAVFE1525CLRG EUDAMEDAVFE1525CLFG EUDAMEDAVFE1725CLRG EUDAMEDAVF1625CPLFG EUDAMEDAVFE1720CPLRG EUDAMEDAVFE1725CPLFG EUDAMEDAVFE1625CPLFG EUDAMEDAVFE1525CYFG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987488098056 EUDAMED04987488097936 EUDAMED04987488098070 EUDAMED04987488097974 EUDAMED04987488098032 EUDAMED04987488097950 EUDAMED04987488098049 EUDAMED04987488097943 EUDAMED04987488098094 EUDAMED04987488097998 EUDAMED04987488097981 EUDAMED04987488098001 EUDAMED
- Basic UDI-DI
- 4987488AVF_HD_KR EUDAMED
- EMDN Code
- A010401 ARTERIOVENOUS FISTULA NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
A. V. Fistula Sets for Hemodialysis by Sb-Kawasumi Laboratories, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4987488AVF_HD_KR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sb-Kawasumi Laboratories, Inc.
- EUDAMED SRN
- JP-MF-000011253
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (12)
- EUDAMED 1ac02eed-42f3-45d9-8231-43365072e7bc 61 fields · synced Jul 30, 2026
- EUDAMED 496ce3a7-3eba-4011-b992-0be5d1b78197 61 fields · synced May 16, 2026
- EUDAMED e7d10ad2-f036-4194-a284-58ad70468003 61 fields · synced May 17, 2026
- EUDAMED 37619d20-5b40-4a4b-8a90-475aeff57d56 61 fields · synced May 17, 2026
- EUDAMED f0c33c16-b00e-42ff-98ae-c54dea287a72 61 fields · synced May 17, 2026
- EUDAMED f9f33e94-ad27-4cba-9cef-f9cbd24da689 61 fields · synced May 18, 2026
- EUDAMED 7b266f32-b970-4ba6-be31-23d581cb078c 61 fields · synced May 18, 2026
- EUDAMED 46924be1-175d-40e5-b3b4-44538f701802 61 fields · synced May 18, 2026
- EUDAMED ce479302-f52c-4449-9aa7-2df9992c4f20 61 fields · synced May 18, 2026
- EUDAMED 6bd7fbd6-046e-42a7-ad1a-778937dc7ce2 61 fields · synced May 18, 2026
- EUDAMED 99d7f046-ce9a-4be9-980a-22be1da3ccfe 61 fields · synced May 18, 2026
- EUDAMED a8ceffdd-ea78-4dbe-bcb9-6dff99f1b9ff 61 fields · synced May 19, 2026