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pH-Fix 4.5 - 10.0 PT
EUDAMEDClass B (EU MDR)
Ref 92121Model pH-Fix 4.5 - 10.0 PT
Identity
- Trade Name
- pH-Fix 4.5 - 10.0 PT EUDAMED
- Device Name
- pH-Fix 4.5 - 10.0 PT EUDAMED
- Model / Reference
- pH-Fix 4.5 - 10.0 PT EUDAMED92121 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04046681003622 EUDAMED
- Basic UDI-DI
- 4046681152337WS EUDAMED
- EMDN Code
- W01010699 CLIN. CHEM. RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
pH-Fix 4.5 - 10.0 PT by MACHEREY-NAGEL GmbH & Co. KG — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4046681152337WS | Class B | Active |
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Manufacturer
- Manufacturer
- MACHEREY-NAGEL GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005636
Sources (1)
- EUDAMED bbec7f8f-32e2-497a-bcdd-08b094e3828c 61 fields · synced Oct 6, 2026