← Back to catalogue
Biocard Chlamydia pneumoniae IgM
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 3-034-000
Identity
- Trade Name
- Biocard Chlamydia pneumoniae IgM EUDAMED
- Device Name
- Biocard Chlamydia pneumoniae IgM EUDAMED
- Model / Reference
- 3-034-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06416842034013 EUDAMED
- Basic UDI-DI
- B-06416842034013 EUDAMED
- EMDN Code
- W0105010116 CHLAMYDIA PNEUMONIAE ANTIBODY IGM EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Biocard Chlamydia pneumoniae IgM by Labsystems Diagnostics Oy — Class IVD Annex II List B — 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-06416842034013 | Class IVD Annex II List B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Labsystems Diagnostics Oy
- EUDAMED SRN
- FI-MF-000018281
Sources (1)
- EUDAMED bded52ea-f4ca-43d5-9e93-6ab48dd8321e 61 fields · synced Jun 19, 2026