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Silicone Flex Tube, 14cm, 22F, 10F
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AB0136Model (Q) Tubing
Identity
- Trade Name
- Silicone Flex Tube, 14cm, 22F, 10F EUDAMEDSil-Flex FDA UDI
- Generic Name
- Breathing circuit catheter mount, reusable FDA UDI
- Device Name
- Reusable Tubing and Hose EUDAMEDReusable Sil.Flex Hose EUDAMEDSil-Flex tube 10F/22F，14cm FDA UDI
- Model / Reference
- AB0136 EUDAMED(Q) Tubing EUDAMED77015 FDA UDI
- Description
- Sil-Flex tube 10F/22F，14cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06923980112409 EUDAMED04710810083303 EUDAMEDFDA UDI
- Basic UDI-DI
- 69239801NR2QASY EUDAMED471081008RNQ197 EUDAMED
- FDA Product Code
- BZO FDA UDI
- EMDN Code
- R020301 RESPIRATORY CIRCUITS CONNECTION PIPES EUDAMEDR02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMED
- GMDN Term
- Breathing circuit catheter mount, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5975 FDA UDI
- Market of Registration
- Denmark EUDAMEDNetherlands 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Silicone Flex Tube, 14cm, 22F, 10F by GaleMed (Xiamen) 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 | 69239801NR2QASY | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GaleMed (Xiamen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020627
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 79dce848-6607-489e-8954-da992c4923c5 61 fields · synced Jul 12, 2026
- FDA UDI 2a276345-b71f-4bad-ad8d-bb4d1cd32057 34 fields · synced May 30, 2026
- EUDAMED 56e0aaa5-59d0-431c-9af9-46303cf323e1 61 fields · synced Jul 12, 2026