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series callibration syringes
EUDAMEDFDA UDIClass I (EU MDR)
Ref 4900 7L SYR 1.375 ID O-RNG"Model 4900; 5510; 5520; 5530; 5540; 5550; 5570Ref 113622Model 4900; 5510; 5520; 5530; 5540; 5550; 5570 Series
Identity
- Trade Name
- 4900 7L SYRINGE FDA UDI
- Generic Name
- Spirometer/pulmonary function analyser syringe FDA UDI
- Device Name
- series callibration syringes EUDAMEDVolume Calibration Syringe EUDAMED4900 7L SYR 1.375 ID O-RNG" FDA UDI
- Model / Reference
- 4900; 5510; 5520; 5530; 5540; 5550; 5570 EUDAMED4900 7L SYR 1.375 ID O-RNG" EUDAMED4900; 5510; 5520; 5530; 5540; 5550; 5570 Series EUDAMED113622 EUDAMED4900 FDA UDI
- Description
- 4900 7L SYR 1.375 ID O-RNG" FDA UDI
Identifiers
- Catalog Number
- 113622 FDA UDI
- Primary DI / UDI-DI
- 00817136021287 EUDAMEDFDA UDI
- Basic UDI-DI
- 081713602691184BU EUDAMED
- FDA Product Code
- BXW FDA UDI
- EMDN Code
- A070199 ADAPTERS AND CONNECTORS - OTHER EUDAMEDR9099 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
- Netherlands EUDAMEDGermany 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 (3)
- EUDAMED fb7d2fea-b4a3-4121-a654-e55548974ddf 61 fields · synced Jul 8, 2026
- FDA UDI 17d9856e-2e14-4cd9-8da8-f5d0df35dc14 34 fields · synced May 30, 2026
- EUDAMED 75785a00-fdd4-4827-b72d-936108254530 61 fields · synced Jun 18, 2026