Spray Catheter
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Spray Catheter FDA UDI
- Generic Name
- Endoscopic spray catheter, single-use FDA UDI
- Device Name
- Spray Catheter EUDAMEDBlue handle 1.8mm OD 1800mm length FDA UDIBlue handle 2.3mm OD 1800mm length FDA UDIBlue handle 2.3mm OD 1000mm length FDA UDIBlue handle 1.8mm OD 2200mm length FDA UDIBlue handle 2.3mm OD 1600mm length FDA UDIBlue handle 1.8mm OD 2500mm length FDA UDI
- Model / Reference
- WP-18/1800 EUDAMEDFDA UDIWP-23/1800 EUDAMEDFDA UDIWP-23/1000 EUDAMEDFDA UDIWP-18/2200 EUDAMEDFDA UDIWP-23/1600 EUDAMEDFDA UDIWP-18/2500 EUDAMEDFDA UDI
- Description
- Blue handle 1.8mm OD 1800mm length FDA UDIBlue handle 2.3mm OD 1800mm length FDA UDIBlue handle 2.3mm OD 1000mm length FDA UDIBlue handle 1.8mm OD 2200mm length FDA UDIBlue handle 2.3mm OD 1600mm length FDA UDIBlue handle 1.8mm OD 2500mm length FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06902284527539 EUDAMED06902284527546 EUDAMED06902284527584 EUDAMED06902284527577 EUDAMED06902284527553 EUDAMED06902284527560 EUDAMED06932503562232 FDA UDI06932503562287 FDA UDI06932503562263 FDA UDI06932503562249 FDA UDI06932503562270 FDA UDI06932503562256 FDA UDI
- Basic UDI-DI
- 6902284WP61511Q5 EUDAMED
- FDA Product Code
- GCE FDA UDI
- EMDN Code
- Z12019007 IRRIGATORS EUDAMED
- GMDN Term
- Endoscopic spray catheter, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Outer Diameter — 1.8 Millimeter FDA UDILength — 180 Centimeter FDA UDIOuter Diameter — 2.3 Millimeter FDA UDILength — 100 Centimeter FDA UDILength — 220 Centimeter FDA UDILength — 160 Centimeter FDA UDILength — 250 Centimeter FDA UDI
Category: Endoscopic spray catheter, single-use
Spray Catheter by Micro-Tech (Nanjing) Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Micro-Tech (Nanjing) Co., Ltd.
Sources (12)
- FDA UDI aa1991f4-d155-42e0-afcc-6e6d284404d7 35 fields · synced Aug 1, 2026
- FDA UDI d66e30d0-52ba-4831-b344-2ebd3480eff5 35 fields · synced May 29, 2026
- FDA UDI 5367a3cc-0b69-41e4-a16e-637a23f4e8b3 35 fields · synced May 30, 2026
- FDA UDI 4f776ffb-cf03-4974-97f9-bb6dfa0f03c7 35 fields · synced May 30, 2026
- FDA UDI 57f21e8e-73d5-485b-bc78-1d4daa12de97 35 fields · synced May 30, 2026
- FDA UDI 1c0e43ed-3810-4ce7-aaa5-b4714c77cb94 35 fields · synced May 30, 2026
- EUDAMED 78f957e5-3205-4f91-a784-7bc5338d5c72 61 fields · synced Jul 11, 2026
- EUDAMED 8615a212-d754-48cf-ae97-a905f37bc5e5 61 fields · synced Jul 15, 2026
- EUDAMED 60441621-191d-42f1-a77c-970866b92fd6 61 fields · synced Jul 20, 2026
- EUDAMED d56c34aa-331d-425e-8e44-0cc0673dfffa 61 fields · synced Jul 25, 2026
- EUDAMED 640eece2-ddba-4078-8cfd-04f540bd8340 61 fields · synced Jul 29, 2026
- EUDAMED d9bb57f4-16b2-48fa-916f-736be147a5e4 61 fields · synced Aug 1, 2026