Identity
- Trade Name
- Hydration Vials EUDAMED
- Device Name
- Dx-Hydration Vials EUDAMED
- Model / Reference
- Dx-020 H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00899994002165 EUDAMED
- Basic UDI-DI
- B-00899994002165 EUDAMED
- EMDN Code
- G030702 PH MONITORING DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hydration Vials by Respiratory Technology Corporation — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00899994002165 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respiratory Technology Corporation
- EUDAMED SRN
- US-MF-000009086
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 8254e6db-f39f-45fd-83f1-37272b7c599e 61 fields · synced Jul 13, 2026