Active working element - round
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Active working element (round ; Fr26; STORZ compatible) EUDAMEDActive working element (SIDE load; round ; Fr26 ; STORZ compatible) FDA UDI
- Generic Name
- Rigid endoscope working guide FDA UDI
- Device Name
- Working Element EUDAMED
- Model / Reference
- V12PR11G EUDAMEDVA1S FDA UDI
Identifiers
- Catalog Number
- VA1S FDA UDI
- Primary DI / UDI-DI
- 03665415000549 EUDAMED03665415002178 FDA UDI
- Basic UDI-DI
- 3665415WorkingElement_IQY EUDAMED
- 510(k) Number
- K213135 FDA UDI
- FDA Product Code
- FAS FDA UDIGEI FDA UDIFDC FDA UDI
- EMDN Code
- U090299 UROGENITAL ENDOSCOPIC RESECTION INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Rigid endoscope working guide FDA UDI
- Models / Variants
- round FDA UDIEUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4300 FDA UDI878.4400 FDA UDI876.1500 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Rigid endoscope working guide
Active working element - round by Lamidey Noury Medical — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 4 models — regulatory data on deviCERTS
Similar devices
Also classified as Rigid endoscope working guide.
- Saline-resectoscopy working unit, passive closed handle, 24/26/28.5Ch — mahe medical gmbh · Class II
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II
- Olympus — Olympus Winter & Ibe GmbH · Class II
- Urethrotome sheath only, 21Ch. — mahe medical gmbh · Class II
- Olympus — Olympus Winter & Ibe GmbH · Class II
- Olympus — Olympus Winter & Ibe GmbH · Class II
- Resectoscopy working unit, passive, closed handle, 24/26/28.5Ch — mahe medical gmbh · Class II
Cleared under the same submission
K213135 also covers:
- Active working element (SIDE load; round ; Fr26 ; OLYMPUS compatible) — LAMIDEY NOURY MEDICAL
- Bipolar cutting loop / THICK (SIDE load; round fitting ; Fr26) — LAMIDEY NOURY MEDICAL
- Bipolar cutting loop / THIN (SIDE load; round fitting ; Fr26) — LAMIDEY NOURY MEDICAL
- Bipolar electrode / NEEDLE (SIDE LOAD.round fitting ; Fr26) — LAMIDEY NOURY MEDICAL
- Bipolar electrode / VAPORIZATION (SIDE load; round fitting ; Fr26) — LAMIDEY NOURY MEDICAL
- Passive working element (SIDE load; round ; Fr26 ; OLYMPUS compatible) — LAMIDEY NOURY MEDICAL
- Passive working element (SIDE load; round ; Fr26 ; STORZ compatible) — LAMIDEY NOURY MEDICAL
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lamidey Noury Medical
Sources (2)
- FDA UDI 4885f491-8b14-4129-a2db-74d89c831ace 35 fields · synced Jul 16, 2026
- EUDAMED 8c9c4c95-dc15-4403-a2a8-758db1463e85 61 fields · synced Jul 16, 2026