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Alpha1- antitrypsin
EUDAMEDClass IVD General (EU MDR)
Ref ATTUR-H00/ADVRef ATTUR-B00/CGRRef ATTUR-H00/AURef ATTUR-B00Ref ATTUR-H00/CGRRef ATTUR-H00/ARCRef ATTUR-B00/AURef ATTUR-L00/CGRRef ATTUR-H00/COBRef ATTUR-L00/ARCRef ATTUR-B00/COBRef ATTUR-L00/ALIRef ATTUR-L00/ATE
by Diagam S.A.
Identity
- Trade Name
- Alpha1- antitrypsin EUDAMED
- Device Name
- Alpha1- antitrypsin EUDAMED
- Model / Reference
- ATTUR-H00/ADV EUDAMEDATTUR-B00/CGR EUDAMEDATTUR-H00/AU EUDAMEDATTUR-B00 EUDAMEDATTUR-H00/CGR EUDAMEDATTUR-H00/ARC EUDAMEDATTUR-B00/AU EUDAMEDATTUR-L00/CGR EUDAMEDATTUR-H00/COB EUDAMEDATTUR-L00/ARC EUDAMEDATTUR-B00/COB EUDAMEDATTUR-L00/ALI EUDAMEDATTUR-L00/ATE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05415168001410 EUDAMED05415168010474 EUDAMED05415168000789 EUDAMED05415168000123 EUDAMED05415168007108 EUDAMED05415168002103 EUDAMED05415168013673 EUDAMED05415168010481 EUDAMED05415168002714 EUDAMED05415168009423 EUDAMED05415168002707 EUDAMED05415168008730 EUDAMED05415168009652 EUDAMED
- Basic UDI-DI
- B-05415168001410 EUDAMEDB-05415168010474 EUDAMEDB-05415168000789 EUDAMEDB-05415168000123 EUDAMEDB-05415168007108 EUDAMEDB-05415168002103 EUDAMEDB-05415168013673 EUDAMEDB-05415168010481 EUDAMEDB-05415168002714 EUDAMEDB-05415168009423 EUDAMEDB-05415168002707 EUDAMEDB-05415168008730 EUDAMEDB-05415168009652 EUDAMED
- EMDN Code
- W0102019002 A1-ANTITRYPSIN (PROTEASE INHIBITOR) 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
Alpha1- antitrypsin 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-05415168001410 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Diagam S.A.
- EUDAMED SRN
- BE-MF-000022993
Sources (13)
- EUDAMED 0523d3d8-b8d2-40be-94e8-36463ff1b433 61 fields · synced Jul 31, 2026
- EUDAMED 6989b064-5902-48ac-b265-a2ae4633e645 61 fields · synced May 16, 2026
- EUDAMED cb0d34db-51f6-4d47-8ac8-2565e33aedf9 61 fields · synced May 16, 2026
- EUDAMED 45cfd1d9-e85a-4038-a4a9-820d30236f12 61 fields · synced May 17, 2026
- EUDAMED 20fc936f-4f07-4e31-809f-b993fb5d8b62 61 fields · synced May 17, 2026
- EUDAMED e58e9347-d76f-4f39-aea9-c7b61f32163a 61 fields · synced May 17, 2026
- EUDAMED 4b49f732-6c16-4ff4-a715-3fa756844c7c 61 fields · synced May 17, 2026
- EUDAMED bbe6d2af-4ead-49c3-9662-9f9d318ce2a9 61 fields · synced May 17, 2026
- EUDAMED 7a166e0b-86ef-42d1-ba69-b944af3f3a53 61 fields · synced May 17, 2026
- EUDAMED ea3568cb-1b43-4ba2-9b73-19a469872adc 61 fields · synced May 18, 2026
- EUDAMED ae52d543-3e5f-46a0-aa9c-b7afda25eef1 61 fields · synced May 18, 2026
- EUDAMED d787894b-13e6-4b50-ac8f-39e4cd444a7c 61 fields · synced May 18, 2026
- EUDAMED d188d0c4-5cd1-43c5-8378-5145974d7d17 61 fields · synced May 18, 2026