Identity
- Trade Name
- HolstOR PRO™ EUDAMEDHolstOR Pro FDA UDI
- Generic Name
- Electrosurgical handpiece/electrode holder, reusable FDA UDI
- Device Name
- Surgical Instrument Holder EUDAMEDFDA UDI
- Model / Reference
- H-PRO-330 EUDAMED330mm FDA UDI
- Description
- Surgical Instrument Holder FDA UDI
Identifiers
- Catalog Number
- HPRO-330 FDA UDI
- Primary DI / UDI-DI
- 09349967002896 EUDAMEDFDA UDI
- Basic UDI-DI
- 93499670INSTHLDR45686TX EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
- GMDN Term
- Electrosurgical handpiece/electrode holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Poland 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 330 Millimeter FDA UDI
HolstOR PRO™ by The O R Company Pty Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 93499670INSTHLDR45686TX | 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 3e0c05e4-30d4-4cf7-96a9-bfbc5e8388e7 61 fields · synced Jul 25, 2026
- FDA UDI b7624db9-383d-462e-948e-97db4005d49f 35 fields · synced May 30, 2026