← Back to catalogue
Automated Nucleic Acid Hybridization System (mAutoMax)
EUDAMEDClass A (EU MDR)
Ref HBHM-3001S
Identity
- Device Name
- Automated Nucleic Acid Hybridization System (mAutoMax) EUDAMED
- Model / Reference
- HBHM-3001S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975157920058 EUDAMED
- Basic UDI-DI
- 697515792HBHM3001SDB EUDAMED
- EMDN Code
- W02050101 NUCLEIC ACID HYBRIDIZATION UNITS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Automated Nucleic Acid Hybridization System (mAutoMax) by Hybribio Medtech Device Co., Ltd — Class A — 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 | 697515792HBHM3001SDB | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hybribio Medtech Device Co., Ltd
- EUDAMED SRN
- CN-MF-000023113
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 61f804b2-3bb4-4b80-8f69-97b966b02d4f 61 fields · synced Jul 27, 2026