← Back to catalogue
CeroFrict
EUDAMEDFDA UDIClass I (EU MDR)
Ref SML004-PY02Model SML004-PY01, SML004-PY01-CC, SML004-PY02, SML004-PY02-FC, SML004-PY02-LC, SML004-PY03, SML004-PY04, SML004-PY05, SML004-PY06, SML004-PY07, SML004-PY08, SML004-PY09, SML004-PY10, SML004-PY11
Identity
- Trade Name
- CeroFrict EUDAMEDFDA UDI
- Generic Name
- Surgical suction system collection container, single-use FDA UDI
- Device Name
- Disposable Polyp Trap EUDAMEDFDA UDI
- Model / Reference
- SML004-PY01, SML004-PY01-CC, SML004-PY02, SML004-PY02-FC, SML004-PY02-LC, SML004-PY03, SML004-PY04, SML004-PY05, SML004-PY06, SML004-PY07, SML004-PY08, SML004-PY09, SML004-PY10, SML004-PY11 EUDAMEDSML004-PY02 EUDAMEDFDA UDI
- Description
- Disposable Polyp Trap FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04897129990048 EUDAMEDFDA UDI
- Basic UDI-DI
- 489712999PY6A EUDAMED
- FDA Product Code
- CBC FDA UDI
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Surgical suction system collection container, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Category: Gastro-urological guidewire, single-use
CeroFrict by SML Med-Tech Solutions Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastro-urological guidewire, single-use.
- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
- aneopiston — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class I
- Tracer Metro — COOK INCORPORATED · Class II
- Sterile Hydro-Slide Guidewire — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Single Use Urinary Guidewire — Zhejiang Chuangxiang Medical Technology Co., LTD. · Class II
- Führungsdraht, "Grip-Wire", Nitinol — MTW - Endoskopie W. Haag KG · Class IIa
- Disposable Endoscopy Adapter Set — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class I
- Optimos™ Guidewire — Taewoong Medical · Class II
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 | 489712999PY6A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SML Med-Tech Solutions Limited
- EUDAMED SRN
- CN-MF-000031313
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED 8221f956-b98e-4f5c-b07a-4914baecf24c 61 fields · synced Jul 24, 2026
- FDA UDI 593daae2-3d47-4dbf-ab80-fd15f7a43013 33 fields · synced May 30, 2026