Identity
- Trade Name
- Catheter Mount EUDAMEDCatheter Mount, Smoothbore, Double Swivel FDA UDI
- Generic Name
- Breathing circuit catheter mount, single-use FDA UDI
- Device Name
- Catheter Mount EUDAMED
- Model / Reference
- PA2911C EUDAMEDFDA UDI
Identifiers
- Catalog Number
- PA2911C FDA UDI
- Primary DI / UDI-DI
- 06923310903660 EUDAMEDFDA UDI
- Basic UDI-DI
- 69233109PA29ME EUDAMED
- FDA Product Code
- CAI FDA UDI
- EMDN Code
- R020299 MOUNT CATHETERS - OTHER EUDAMED
- GMDN Term
- Breathing circuit catheter mount, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5240 FDA UDI
- Market of Registration
- Poland 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
Catheter Mount by Hangzhou Formed Medical Devices Co., Ltd. — Class IIa — 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 | 69233109PA29ME | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou Formed Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000011212
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED d06f6b6c-c9ae-40d1-8b5c-328399a8cdfb 61 fields · synced Jul 10, 2026
- FDA UDI 058ba63b-ea8e-4fa8-a8ce-4aa7696a059c 33 fields · synced May 30, 2026