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Diathermy handpiece, short
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref VE201712Model MD0105.112 HF-Surgical Handpieces Reusable
Identity
- Trade Name
- Diathermy handpiece, short EUDAMEDOertli® FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- DATHERMIE HANDSTUECK KURZ; DIATHERMY HANDPIECE SHORT; MANCHE COURT POUR POINTES DIA FDA UDI
- Model / Reference
- MD0105.112 HF-Surgical Handpieces Reusable EUDAMEDVE201712 EUDAMEDFDA UDI
- Description
- DATHERMIE HANDSTUECK KURZ; DIATHERMY HANDPIECE SHORT; MANCHE COURT POUR POINTES DIA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003900415 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300039MD0105112V2 EUDAMED
- Direct Marketing DI
- 07630003900415 EUDAMED
- FDA Product Code
- HQC FDA UDI
- EMDN Code
- Q020699 PHACOEMULSIFICATION DEVICES - OTHER EUDAMED
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4670 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Diathermy handpiece, short by Oertli Instrumente Ag — Class IIb — 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 | 76300039MD0105112V2 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Oertli Instrumente AG
- EUDAMED SRN
- CH-MF-000016175
- Authorised Representative
- Oertli Ophthalmedic Österreich GmbH AT-AR-000003554
Sources (2)
- EUDAMED 0c63fbbb-9135-42e2-893e-443f5224cc18 61 fields · synced Jun 18, 2026
- FDA UDI bff85698-7b03-451b-ad20-6c199a91f969 34 fields · synced May 30, 2026