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series callibration syringes
EUDAMEDFDA UDIClass I (EU MDR)
Ref CR1167AModel 4900; 5510; 5520; 5530; 5540; 5550; 5570
Identity
- Trade Name
- 5510 100ML SYRINGE FDA UDI
- Generic Name
- Spirometer/pulmonary function analyser syringe FDA UDI
- Device Name
- series callibration syringes EUDAMEDCUSTOM 5510 ROD/10ml INCR MARK FDA UDI
- Model / Reference
- 4900; 5510; 5520; 5530; 5540; 5550; 5570 EUDAMEDCR1167A EUDAMED5510 FDA UDI
- Description
- CUSTOM 5510 ROD/10ml INCR MARK FDA UDI
Identifiers
- Catalog Number
- CR1167A FDA UDI
- Primary DI / UDI-DI
- 00817136023137 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 454c4eaa-aae4-49e6-9ccc-32d3a4cc32a6 61 fields · synced Jun 18, 2026
- FDA UDI 17a8c6dd-2f0c-4b35-974a-32f23bcb444c 34 fields · synced May 30, 2026