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Volume Calibration Syringe
EUDAMEDClass I (EU MDR)
Ref 113906Model 4900; 5510; 5520; 5530; 5540; 5550; 5570 Series
Identity
- Device Name
- Volume Calibration Syringe EUDAMED
- Model / Reference
- 4900; 5510; 5520; 5530; 5540; 5550; 5570 Series EUDAMED113906 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817136026183 EUDAMED
- Basic UDI-DI
- 081713602691184BU EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulmonary function analysis system, adult
Volume Calibration Syringe by Hans Rudolph, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081713602691184BU | Class I | Active |
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Manufacturer
- Manufacturer
- Hans Rudolph Inc
- EUDAMED SRN
- US-MF-000004498
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (1)
- EUDAMED 73eadfaf-fdc8-4bda-85d2-91dd16fc6f74 61 fields · synced Jun 19, 2026