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Capsulotomy tip, standard
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref VE201726Model MD0105.137 Capsulotomy Tips Reusable
Identity
- Trade Name
- Capsulotomy tip, standard EUDAMEDOertli® FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- KAPSULOTOMIE-SPITZE, STANDARD; CAPSULOTOMY PLUG REGULAR; POINTE CAPSULOTOMIE NORMALE FDA UDI
- Model / Reference
- MD0105.137 Capsulotomy Tips Reusable EUDAMEDVE201726 EUDAMEDFDA UDI
- Description
- KAPSULOTOMIE-SPITZE, STANDARD; CAPSULOTOMY PLUG REGULAR; POINTE CAPSULOTOMIE NORMALE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630003900477 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300039MD0105137VJ EUDAMED
- Direct Marketing DI
- 07630003900477 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
Capsulotomy tip, standard 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 | 76300039MD0105137VJ | 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 2405f974-e360-4656-b5f7-0433dcc9bd30 61 fields · synced Jun 19, 2026
- FDA UDI 0dbab3da-661a-4ea0-a3c1-ac9347b9dbda 34 fields · synced May 30, 2026