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2-lumen Catheter for Cystometry and Urethral
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 9021P5062
Identity
- Trade Name
- 2-lumen Catheter for Cystometry and Urethral FDA UDI
- Generic Name
- Urodynamic manometric catheter, non-electronic FDA UDI
- Device Name
- 2-lumen Catheter for Cystometry and Urethral EUDAMED
- Model / Reference
- 9021P5062 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 10627825007082 EUDAMEDFDA UDI
- Basic UDI-DI
- 062782501N9 EUDAMED
- FDA Product Code
- FEN FDA UDI
- EMDN Code
- Z12160485 URODYNAMICS INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Urodynamic manometric catheter, non-electronic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1620 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
2-lumen Catheter for Cystometry and Urethral by Laborie Medical Technologies Corp. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 062782501N9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Laborie Medical Technologies Corp.
- EUDAMED SRN
- US-MF-000022925
- Authorised Representative
- Medical Measurement Systems B.V. NL-AR-000010438
Sources (2)
- EUDAMED 2cc7c9be-0aeb-49f7-84fd-96afa5b4a2c9 61 fields · synced Jul 10, 2026
- FDA UDI cbf4ba05-4732-45f0-8ac1-02ff40729d0b 32 fields · synced May 29, 2026