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Immunoglobulin M
EUDAMEDClass IVD General (EU MDR)
Ref IMTUR-L00/ARCRef IMTUR-L00Ref IMTUR-H00Ref IMTUR-L00/COBRef IMTUR-H00/CGRRef IMTUR-L00/UDARef IMTUR-B00/AURef IMTUR-L00/AURef IMTUR-H00/ADVRef IMTUR-B00/ATERef IMTUR-H00/COBRef IMTUR-B00Ref IMTUR-B00/COBRef IMTUR-L00/ADVRef IMTUR-H00/AURef IMTUR-L00/CGRRef IMTUR-L00/ALI
by Diagam S.A.
Identity
- Trade Name
- Immunoglobulin M EUDAMED
- Device Name
- Immunoglobulin M EUDAMED
- Model / Reference
- IMTUR-L00/ARC EUDAMEDIMTUR-L00 EUDAMEDIMTUR-H00 EUDAMEDIMTUR-L00/COB EUDAMEDIMTUR-H00/CGR EUDAMEDIMTUR-L00/UDA EUDAMEDIMTUR-B00/AU EUDAMEDIMTUR-L00/AU EUDAMEDIMTUR-H00/ADV EUDAMEDIMTUR-B00/ATE EUDAMEDIMTUR-H00/COB EUDAMEDIMTUR-B00 EUDAMEDIMTUR-B00/COB EUDAMEDIMTUR-L00/ADV EUDAMEDIMTUR-H00/AU EUDAMEDIMTUR-L00/CGR EUDAMEDIMTUR-L00/ALI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05415168009270 EUDAMED05415168008068 EUDAMED05415168000499 EUDAMED05415168015547 EUDAMED05415168011099 EUDAMED05415168003599 EUDAMED05415168000987 EUDAMED05415168013963 EUDAMED05415168001793 EUDAMED05415168010146 EUDAMED05415168003070 EUDAMED05415168000482 EUDAMED05415168003063 EUDAMED05415168008532 EUDAMED05415168000994 EUDAMED05415168011105 EUDAMED05415168009003 EUDAMED
- Basic UDI-DI
- B-05415168009270 EUDAMEDB-05415168008068 EUDAMEDB-05415168000499 EUDAMEDB-05415168015547 EUDAMEDB-05415168011099 EUDAMEDB-05415168003599 EUDAMEDB-05415168000987 EUDAMEDB-05415168013963 EUDAMEDB-05415168001793 EUDAMEDB-05415168010146 EUDAMEDB-05415168003070 EUDAMEDB-05415168000482 EUDAMEDB-05415168003063 EUDAMEDB-05415168008532 EUDAMEDB-05415168000994 EUDAMEDB-05415168011105 EUDAMEDB-05415168009003 EUDAMED
- EMDN Code
- W0102010107 IMMUNOGLOBULIN M EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Immunoglobulin M by Diagam S.A. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05415168009270 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Diagam S.A.
- EUDAMED SRN
- BE-MF-000022993
Sources (17)
- EUDAMED 17f4e6fc-8d61-4aa3-ad74-23a415987c82 61 fields · synced Sep 18, 2026
- EUDAMED 4b625623-e128-4282-9067-b9b42e70ec79 61 fields · synced May 11, 2026
- EUDAMED e44c637b-d79a-4e72-9097-18cb3def69a4 61 fields · synced May 16, 2026
- EUDAMED 4a578a72-28f2-48b5-8d6f-b79e945ec130 61 fields · synced May 16, 2026
- EUDAMED 26e53064-61ef-431b-a71f-2146bc3f0746 61 fields · synced May 16, 2026
- EUDAMED a31d0c01-8f83-4b8a-b13e-9e9f13c7d32a 61 fields · synced May 17, 2026
- EUDAMED 21f6ae22-bdf6-497f-bba8-5c76606ccc0d 61 fields · synced May 17, 2026
- EUDAMED 3697d4eb-bfea-42b8-af2c-a677893f7b20 61 fields · synced May 17, 2026
- EUDAMED 56af88a6-7b13-421b-a1fc-ff0b6c7f7a27 61 fields · synced May 17, 2026
- EUDAMED 26809ce3-148e-47e9-88d0-1ed9e19c0e6b 61 fields · synced May 17, 2026
- EUDAMED 6d2d680c-7027-4241-ad1c-5e90dea8c5ce 61 fields · synced May 17, 2026
- EUDAMED f5cfd084-c662-4153-bf6e-58708976372b 61 fields · synced May 17, 2026
- EUDAMED de3b9e49-7784-4024-92e7-faddf956d15f 61 fields · synced May 18, 2026
- EUDAMED 322850ec-0ae0-4123-aaac-9cd3e2f613fe 61 fields · synced May 18, 2026
- EUDAMED 1c723f48-1e1a-4b1a-a29f-5e4473bbae0a 61 fields · synced May 19, 2026
- EUDAMED d9a0779a-9200-41a9-a106-ab462d9606d2 61 fields · synced May 19, 2026
- EUDAMED 3c977921-93ed-4e8d-8259-a83fccd46317 61 fields · synced May 19, 2026