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BioCLIA Autoimmune Reagent Kit, PM-Scl
EUDAMEDClass IVD General (EU MDR)
Ref MY00158Model PM-Scl, 100 Tests/KitRef MY00107CModel PM-Scl, 50 Tests/Kit
Identity
- Trade Name
- BioCLIA Autoimmune Reagent Kit, PM-Scl EUDAMED
- Device Name
- BioCLIA Autoimmune Reagent Kit, PM-Scl EUDAMED
- Model / Reference
- PM-Scl, 100 Tests/Kit EUDAMEDMY00158 EUDAMEDPM-Scl, 50 Tests/Kit EUDAMEDMY00107C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924030402730 EUDAMED06924030415563 EUDAMED
- Basic UDI-DI
- B-06924030402730 EUDAMEDB-06924030415563 EUDAMED
- EMDN Code
- W0102100109 PM-SCL - ANTIBODIES EUDAMEDW0102100199 AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
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
BioCLIA Autoimmune Reagent Kit, PM-Scl by HOB Biotech Group Corp., 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-06924030402730 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- HOB Biotech Group Corp., Ltd.
- EUDAMED SRN
- CN-MF-000023974
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 04c9efa5-f36c-426a-851f-d9660b7f41ce 61 fields · synced Oct 6, 2026
- EUDAMED 29ac4f35-9b20-4e4f-8dec-2b8682679a25 61 fields · synced May 19, 2026