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Aptra
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BDSD01Model OTU-100RL, OTU-100RR, OTU-100SL, OTU-100SR, OTU-120R, OTU-120S,
Identity
- Trade Name
- Aptra EUDAMEDFDA UDI
- Generic Name
- Flexible video ureteroscope, single-use FDA UDI
- Device Name
- Single-Use Digital Flexible Ureteroscope EUDAMEDFDA UDI
- Model / Reference
- OTU-100RL, OTU-100RR, OTU-100SL, OTU-100SR, OTU-120R, OTU-120S, EUDAMEDBDSD01 EUDAMEDFDA UDI
- Description
- Single-Use Digital Flexible Ureteroscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850023925022 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850023925002RF EUDAMED
- 510(k) Number
- K181977 FDA UDI
- FDA Product Code
- FGB FDA UDI
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMED
- GMDN Term
- Flexible video ureteroscope, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible video ureteroscope, single-use
Aptra by Otu Medical Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video ureteroscope, single-use.
- Single-use Flexible Uretero-Renoscope — Zhuhai Vision Medical Technology Co., Ltd · Class IIa
- Ureterorenoscope — Innoview GmbH · Class IIa
- URS. 040.00.1500 — Blazejewski MEDI-TECH GmbH · Class IIa
- CoralView® — MacroLux Medical Technology Co., Ltd. · Class II
- LithoVue — Boston Scientific · Class II
- Single-use Digital Flexible Ureterorenoscopes — NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- Flexible Ureterorenoscopes — Shanghai Anqing Medical Instrument Co., Ltd · Class IIa
- SEPLOU — Seplou (Zhuhai) Co., Ltd. · 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 | 0850023925002RF | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Otu Medical Inc.
- EUDAMED SRN
- US-MF-000020690
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 096841fb-a87a-4d09-838d-758cb306cc12 61 fields · synced May 30, 2026
- FDA UDI 364f389a-4f41-4e9b-ae31-3482dbcc62c0 34 fields · synced May 30, 2026