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series callibration syringes
EUDAMEDFDA UDIClass I (EU MDR)
Ref 112234Model 4900; 5510; 5520; 5530; 5540; 5550; 5570
Identity
- Trade Name
- 4900 7L SYRINGE FDA UDI
- Generic Name
- Spirometer/pulmonary function analyser syringe FDA UDI
- Device Name
- series callibration syringes EUDAMED4900A 7L SYR 1.75OD TPR OUTLET FDA UDI
- Model / Reference
- 4900; 5510; 5520; 5530; 5540; 5550; 5570 EUDAMED112234 EUDAMED4900 FDA UDI
- Description
- 4900A 7L SYR 1.75OD TPR OUTLET FDA UDI
Identifiers
- Catalog Number
- 112234 FDA UDI
- Primary DI / UDI-DI
- 00874750008193 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
series callibration syringes by Hans Rudolph, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 |
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Manufacturer
- Manufacturer
- Hans Rudolph Inc
- EUDAMED SRN
- US-MF-000004498
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (2)
- EUDAMED e4fc6c81-0ab2-48f2-a2bf-2951d8711e23 61 fields · synced Jun 18, 2026
- FDA UDI fb03a6a7-e095-49b2-9fa4-f6c4180f9f78 34 fields · synced May 30, 2026