Identity
- Trade Name
- Scope HelpOR™ EUDAMEDScope HelpOR FDA UDI
- Generic Name
- Instrument warmer, electric FDA UDI
- Device Name
- Laparoscopic cleaning and defogging device EUDAMED
- Model / Reference
- SHK-01 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 09349967003206 EUDAMEDFDA UDI
- Basic UDI-DI
- 93499670SCPEWRMR36816W7 EUDAMED
- FDA Product Code
- NWV FDA UDI
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
- GMDN Term
- Instrument warmer, electric FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 884.1720 FDA UDI
- Market of Registration
- Ireland 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
Category: Surgical retractor/retraction system blade, single-use
Scope HelpOR™ by The O R Company Pty Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical retractor/retraction system blade, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 93499670SCPEWRMR36816W7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- The O R Company Pty Ltd
- EUDAMED SRN
- AU-MF-000010179
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED f3d32dd9-d1bb-4000-a80b-b5bcacc5dcb9 61 fields · synced Jun 18, 2026
- FDA UDI 48512f32-3179-4c8e-8ea4-567fb7a101df 32 fields · synced May 30, 2026