ROEKO GuttaFlow2 (UDI REFILL PACK DUAL-BARREL SYRING)
Manufactured by Coltne/Whaledent GmbH + Co. KG
Device Regulatory Overview
The ROEKO GuttaFlow2 (Model/Catalog Number: REFILL PACK DUAL-BARREL SYRING) is a medical device manufactured by Coltne/Whaledent GmbH + Co. KG. This product is indexed under FDA Product Code / Category Classification KIF within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- REFILL PACK DUAL-BARREL SYRING
- Product Code / EMDN
- KIF
- Device Name
- Database Sync Date
- 2026-08-09 09:07:42
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of ROEKO GuttaFlow2?
The registered manufacturer of record for ROEKO GuttaFlow2 is Coltne/Whaledent GmbH + Co. KG.
What is the Primary UDI-DI identifier for ROEKO GuttaFlow2?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is REFILL PACK DUAL-BARREL SYRING.
What classification code is assigned to this device?
This device is registered under product classification code KIF.
Similar Classification Devices (KIF)
Other Devices by Coltne/Whaledent GmbH + Co. KG
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