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Specific Protein Control Serum
EUDAMEDClass IVD General (EU MDR)
Ref 3003151Model Level1: 1×1mLRef 3024987Model Level 2: 8×1mLRef 3025081Model Level 2: 2×1mLRef 3025010Model Level 1: 1×1mLRef 3025013Model Level 2: 5×1mL
Identity
- Trade Name
- Specific Protein Control Serum EUDAMEDSpecific Protein Control EUDAMED
- Device Name
- Specific Protein Control Serum EUDAMEDSpecific Protein Control EUDAMED
- Model / Reference
- Level1: 1×1mL EUDAMED3003151 EUDAMEDLevel 2: 8×1mL EUDAMED3024987 EUDAMEDLevel 2: 2×1mL EUDAMED3025081 EUDAMEDLevel 1: 1×1mL EUDAMED3025010 EUDAMEDLevel 2: 5×1mL EUDAMED3025013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202247200 EUDAMED06942202228704 EUDAMED06942202228667 EUDAMED06942202228599 EUDAMED06942202228681 EUDAMED
- Basic UDI-DI
- B-06942202247200 EUDAMEDB-06942202228704 EUDAMEDB-06942202228667 EUDAMEDB-06942202228599 EUDAMEDB-06942202228681 EUDAMED
- EMDN Code
- W0101050299 SPECIFIC CONTROLS (CC) - OTHER EUDAMEDW0102152003 SPECIFIC PROTEIN CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
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
Specific Protein Control Serum by Dirui Industrial Co., Ltd — 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-06942202247200 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (5)
- EUDAMED 95487d95-cd88-499a-b22b-3e4de88786fe 61 fields · synced Jul 26, 2026
- EUDAMED 84b4890b-d61b-486d-93d6-e253189780c4 61 fields · synced Jun 20, 2026
- EUDAMED b67bda5c-d270-42cc-8016-e641c1f30d0d 61 fields · synced Jul 12, 2026
- EUDAMED 50301291-39ec-4dde-b73d-830c8469a970 61 fields · synced Jul 16, 2026
- EUDAMED 21a2609b-993d-4bb7-8c90-508aa3c331fa 61 fields · synced Jul 21, 2026