← Back to catalogue
series callibration syringes
EUDAMEDFDA UDIClass I (EU MDR)
Ref 112710Model 4900; 5510; 5520; 5530; 5540; 5550; 5570
Identity
- Trade Name
- 5540 1L SYRINGE FDA UDI
- Generic Name
- Spirometer/pulmonary function analyser syringe FDA UDI
- Device Name
- series callibration syringes EUDAMED5540D 1L SYR 1.125/22MM OUTLET FDA UDI
- Model / Reference
- 4900; 5510; 5520; 5530; 5540; 5550; 5570 EUDAMED112710 EUDAMED5540 FDA UDI
- Description
- 5540D 1L SYR 1.125/22MM OUTLET FDA UDI
Identifiers
- Catalog Number
- 112710 FDA UDI
- Primary DI / UDI-DI
- 00874750009916 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 |
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 d72f679d-61cf-4adf-b5cb-20d9c2908a79 61 fields · synced Jun 17, 2026
- FDA UDI b97427b7-4c5d-4c71-8c83-df2fd33bf58f 34 fields · synced May 26, 2026