← Back to catalogue
CeroFrict®
EUDAMEDFDA UDIClass I (EU MDR)
Ref SML002-LP16-PG-NSModel SML001-PT10-NSRef SML001-PT22-PG-NSRef SML002-LP17-PG-NSRef SML003-FJ28-PG-NSRef SML002-LP07-NSRef SML001-PT23-PG-NSRef SML004-PY02-FCModel 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-PY11Ref SML001-PT06Model SML001-PTRef SML003-FJ14Model SML003-FJRef SML001-PT05Ref SML003-FJ22Ref SML001-PT01Ref SML001-PT09Ref SML002-LP08Model SML002-LPRef SML003-FJ27Ref SML001-PT02Ref SML003-FJ25Ref SML002-LP02Ref SML003-FJ13Ref SML003-FJ21Ref SML002-LP14Ref SML003-FJ12Ref SML003-FJ15Ref SML003-FJ18Ref SML003-FJ23Ref SML003-FJ02Ref SML003-FJ03Ref SML002-LP11Ref SML002-LP05Ref SML003-FJ08Ref SML001-PT03Ref SML002-LP01Ref SML001-PT07Ref SML002-LP15
Identity
- Trade Name
- CeroFrict® EUDAMEDCeroFrict FDA UDI
- Generic Name
- Endoscope air/water valve, single-use FDA UDI
- Device Name
- Disposable Endoscope Valve Sets EUDAMEDFDA UDIDisposable Polyp Trap EUDAMED
- Model / Reference
- SML001-PT10-NS EUDAMEDSML002-LP16-PG-NS EUDAMEDSML001-PT22-PG-NS EUDAMEDSML002-LP17-PG-NS EUDAMEDSML003-FJ28-PG-NS EUDAMEDSML002-LP07-NS EUDAMEDSML001-PT23-PG-NS EUDAMEDSML004-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-FC EUDAMEDSML001-PT01 EUDAMEDFDA UDISML001-PT03 EUDAMEDFDA UDISML001-PT07 EUDAMEDFDA UDISML001-PT02 EUDAMEDFDA UDISML002-LP02 EUDAMEDFDA UDISML002-LP01 EUDAMEDFDA UDISML001-PT05 EUDAMEDFDA UDISML001-PT06 EUDAMEDFDA UDISML001-PT09 EUDAMEDFDA UDISML002-LP08 EUDAMEDFDA UDISML002-LP05 EUDAMEDFDA UDISML003-FJ03 EUDAMEDFDA UDISML003-FJ08 EUDAMEDFDA UDISML003-FJ02 EUDAMEDFDA UDISML001-PT EUDAMEDSML003-FJ EUDAMEDSML003-FJ14 EUDAMEDSML003-FJ22 EUDAMEDSML002-LP EUDAMEDSML003-FJ27 EUDAMEDSML003-FJ25 EUDAMEDSML003-FJ13 EUDAMEDSML003-FJ21 EUDAMEDSML002-LP14 EUDAMEDSML003-FJ12 EUDAMEDSML003-FJ15 EUDAMEDSML003-FJ18 EUDAMEDSML003-FJ23 EUDAMEDSML002-LP11 EUDAMEDSML002-LP15 EUDAMED
- Description
- Disposable Endoscope Valve Sets FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04897129991212 EUDAMED04897129991199 EUDAMED04897129991250 EUDAMED04897129991229 EUDAMED04897129991236 EUDAMED04897129991267 EUDAMED04897129991205 EUDAMED04897129991328 EUDAMED04897129990437 EUDAMEDFDA UDI04897129990451 EUDAMEDFDA UDI04897129990499 EUDAMEDFDA UDI04897129990444 EUDAMEDFDA UDI04897129990567 EUDAMEDFDA UDI04897129990550 EUDAMEDFDA UDI04897129990475 EUDAMEDFDA UDI04897129990482 EUDAMEDFDA UDI04897129990512 EUDAMEDFDA UDI04897129990628 EUDAMEDFDA UDI04897129990598 EUDAMEDFDA UDI04897129990666 EUDAMEDFDA UDI04897129990710 EUDAMEDFDA UDI04897129990659 EUDAMEDFDA UDI04897129991052 EUDAMED04897129991137 EUDAMED04897129991182 EUDAMED04897129991168 EUDAMED04897129991045 EUDAMED04897129991120 EUDAMED04897129990994 EUDAMED04897129991038 EUDAMED04897129991069 EUDAMED04897129991090 EUDAMED04897129991144 EUDAMED04897129990963 EUDAMED04897129991007 EUDAMED
- Basic UDI-DI
- 489712999NS5Q EUDAMED489712999PY6A EUDAMED489712999SML001UV EUDAMED489712999SML003UZ EUDAMED489712999SML002UX EUDAMED
- 510(k) Number
- K220884 FDA UDI
- FDA Product Code
- ODC FDA UDI
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMEDG030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Endoscope air/water valve, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDEUDAMEDFDA 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
No
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 | 489712999NS5Q | 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 (49)
- EUDAMED dcc29b14-0b78-42e2-a6bf-ddfe7ea55c74 61 fields · synced Sep 18, 2026
- EUDAMED 1dd7ee92-f679-4437-8653-2d443e1d3dae 61 fields · synced May 17, 2026
- EUDAMED 5d43ec65-a25a-4f8e-ab87-21957e3d224b 61 fields · synced May 17, 2026
- EUDAMED 86143c25-b719-43fc-be84-31fde900268d 61 fields · synced May 17, 2026
- EUDAMED dee1449e-5acd-44a0-9139-26af9578754c 61 fields · synced May 18, 2026
- EUDAMED edd0e6d3-b97f-4b63-b775-06fe9b9c9d20 61 fields · synced May 18, 2026
- EUDAMED f3e615da-751d-49d4-8f13-b3f71cc9e765 61 fields · synced May 18, 2026
- EUDAMED d7d9079b-3985-4a59-b146-396e8652ee44 61 fields · synced May 18, 2026
- FDA UDI d652c14c-b536-43d6-96b7-a191a3773637 34 fields · synced May 29, 2026
- FDA UDI c51d608c-a141-4319-9220-b75ac676b02e 34 fields · synced May 29, 2026
- FDA UDI 35a40c37-e704-4fb2-8ad9-2ae30ebea54d 34 fields · synced May 30, 2026
- FDA UDI 29ba254c-1a9a-4965-87d5-05b0f5910d75 34 fields · synced May 30, 2026
- FDA UDI c6c1ddea-0259-4a52-974a-dd778e40ac52 34 fields · synced May 30, 2026
- FDA UDI 6d98d68c-8fa1-4e44-b409-bfa1efd97c99 34 fields · synced May 30, 2026
- FDA UDI 1964e411-a1c3-4dd9-b977-2bd0199b4c9d 34 fields · synced May 30, 2026
- FDA UDI f54f3344-9362-4152-bd26-7b940ad87b50 34 fields · synced May 30, 2026
- FDA UDI 199710f2-6757-46a4-9fd3-2f9b8b1cf15b 34 fields · synced May 30, 2026
- FDA UDI 96b3717b-c651-4d1a-9c5a-1f057131c568 34 fields · synced May 30, 2026
- FDA UDI d2ddb302-3079-41d4-b4c5-c1a9fbb8050c 34 fields · synced May 30, 2026
- FDA UDI f6a84f0f-1784-4478-887d-cb5d331a84fc 34 fields · synced May 30, 2026
- FDA UDI 089bbf44-c86c-4882-a2ea-e53d7fec12d3 34 fields · synced May 30, 2026
- FDA UDI 9edcc694-5cbb-4ffd-b85a-8be862cd2a0e 34 fields · synced May 30, 2026
- EUDAMED 827cd61d-9813-420e-bd4e-6ecf65fe31f4 61 fields · synced Jul 8, 2026
- EUDAMED 7d779939-1c51-43c4-a360-c9c042ecc9a8 61 fields · synced Jul 8, 2026
- EUDAMED f26c2f22-4c38-4963-aed6-707e2952fc45 61 fields · synced Jul 9, 2026
- EUDAMED 15fb102c-2475-4349-a34d-d6c56fdd7307 61 fields · synced Jul 9, 2026
- EUDAMED fd0bae2b-5429-40e4-abcf-2e85f3c39092 61 fields · synced Jul 9, 2026
- EUDAMED a5037933-2099-4190-842c-48db567fe766 61 fields · synced Jul 10, 2026
- EUDAMED bdc5b184-8960-472b-aa62-ec4a0a9b974b 61 fields · synced Jul 10, 2026
- EUDAMED dd89ed20-8ca1-49bd-b903-ab99497b9cc1 61 fields · synced Jul 10, 2026
- EUDAMED 5554181d-9f81-4313-bc62-86abd5dc1d93 61 fields · synced Jul 10, 2026
- EUDAMED 7e459dee-7aab-4254-8a6b-2433df2ccd67 61 fields · synced Jul 11, 2026
- EUDAMED 5f7ca9f2-1c89-4ab5-9d76-077a718ce34b 61 fields · synced Jul 11, 2026
- EUDAMED f8e0a464-8fba-44b5-9ec7-384c4a42f558 61 fields · synced Jul 12, 2026
- EUDAMED e85a445f-a987-4077-988e-abb9f532fb0f 61 fields · synced Jul 12, 2026
- EUDAMED 44d1daf5-4d13-469d-be66-d9636cf8ab95 61 fields · synced Jul 16, 2026
- EUDAMED 40b65ae5-b4d3-4209-ae0f-519525a42ba1 61 fields · synced Jul 16, 2026
- EUDAMED 6068e0b3-d793-4466-9967-d136dfbfb696 61 fields · synced Jul 16, 2026
- EUDAMED ac8821ad-4d1b-4487-97ff-9f3e2d4ac37c 61 fields · synced Jul 17, 2026
- EUDAMED b8f0ec6f-d52a-45cf-b797-b5e65a3650d7 61 fields · synced Jul 18, 2026
- EUDAMED 65e4b345-fd2e-4c8d-97bd-1f59b25c697a 61 fields · synced Jul 20, 2026
- EUDAMED 7cc7a943-f3db-4ab0-a4ab-650f04908b18 61 fields · synced Jul 21, 2026
- EUDAMED 9a3a3c5c-df96-4834-ab28-196af5a0360e 61 fields · synced Jul 21, 2026
- EUDAMED a6d6fed3-5f78-426f-bed8-ddbeb7c94d03 61 fields · synced Jul 27, 2026
- EUDAMED d89ff597-d495-4e1e-9e1d-c1b2eb50837c 61 fields · synced Jul 31, 2026
- EUDAMED d95ea0f3-cd46-4f1b-aa49-4db893d9ee98 61 fields · synced Aug 2, 2026
- EUDAMED 75a33df0-5c39-4eec-a6df-92ad5201e3ca 61 fields · synced Aug 2, 2026
- EUDAMED 3808d194-51db-4311-93bd-2830547fc637 61 fields · synced Aug 2, 2026
- EUDAMED 0df4b73c-d340-4474-ab8b-e94f6f26e6fd 61 fields · synced Sep 18, 2026