series callibration syringes
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- 5550 1/2L SYRINGE FDA UDI
- Generic Name
- Spirometer/pulmonary function analyser syringe FDA UDI
- Device Name
- series callibration syringes EUDAMED5550D 1/2L SYR 1.125/22MM OUTL FDA UDI
- Model / Reference
- 4900; 5510; 5520; 5530; 5540; 5550; 5570 EUDAMED112746 EUDAMED5550 FDA UDI
- Description
- 5550D 1/2L SYR 1.125/22MM OUTL FDA UDI
Identifiers
- Catalog Number
- 112746 FDA UDI
- Primary DI / UDI-DI
- 00874750009961 EUDAMEDFDA UDI
- Basic UDI-DI
- 081713602691184BU EUDAMED
- FDA Product Code
- BXW FDA UDI
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Spirometer/pulmonary function analyser syringe FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.1870 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Pulmonary function analysis system, adult
series callibration syringes by Hans Rudolph, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary function analysis system, adult.
- VISCOFLU — PHARMA LINE Srl · Class IIb
- CUSTOM PACK FOR NON-INVASIVE VENTILATION — Intersurgical SpA · Class IIa
- Vyaire — Jaeger Medical GmbH · Class II
- AEROCHAMBER PLUS FLOW-VU — TRUDELL MEDICAL INTERNATIONAL · Class I
- Shape II System Refurbished — Shape Medical Systems, Inc. · Class II
- CUSTOM PACK FOR NON-INVASIVE VENTILATION — Intersurgical SpA · Class IIa
- Demand Valve, 3M Hose - AGA (NORDIC) Probe — BNOS MediTECH · Class IIa
- MGC Diagnostics — MEDICAL GRAPHICS CORP. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081713602691184BU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hans Rudolph Inc
- EUDAMED SRN
- US-MF-000004498
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (2)
- EUDAMED 745f08db-0ecd-412a-9f8a-813d2b2f460b 61 fields · synced Jun 18, 2026
- FDA UDI a3a8c464-140d-4ee3-9458-faccfab7043c 34 fields · synced May 30, 2026