Blue Sky Bio, LLC

SRN: US-MF-000014016 · Liberty Drive 800, 60048 Libertyville, United States

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Basic UDI-DIs

Total Devices

319

On Market

319

Off Market

Certificates

Valid

Expiring < 6mo

Countries

Basic Information

Address: Liberty Drive 800, 60048 Libertyville, United States
Email: [email protected]
Phone: 8476822688

Regulatory Overview

Regulation

Eu Mdr 9

Classification

Eu Md Class 1 7

Eu Md Class 2a 2

Device Types

Certificate Health

No certificates registered for this manufacturer.

Market Presence

Devices from this manufacturer are available in 7 countries across Europe.

🇦🇹 Austria 🇩🇪 Germany 🇬🇷 Greece 🇫🇷 France 🇮🇪 Ireland 🇮🇹 Italy 🇵🇹 Portugal

Device Portfolio

Name	Regulation	Classification	Market Status
"Analog Implant Level Internal Octagon – Narrow	EU MDR	Eu Md Class 1	On Market
"Analog Implant Level Internal Octagon – Regular Platform	EU MDR	Eu Md Class 1	On Market
2.0 Diameter Initial Drill	EU MDR	Eu Md Class 2a	On Market
Analog BIO \| Conus 12 / 3.0	EU MDR	Eu Md Class 1	On Market
Analog BIO \| Conus 12 Implant Level 3.5/4.0 Platform	EU MDR	Eu Md Class 1	On Market
Analog Implant Level Internal Octagon – Wide Platform	EU MDR	Eu Md Class 1	On Market
Analog Level Internal Hex 3.5mm Platform	EU MDR	Eu Md Class 1	On Market
Analog Level Internal Hex 4.5mm Platform	EU MDR	Eu Md Class 1	On Market
Analog Multi Unit Abutment	EU MDR	Eu Md Class 1	On Market
Analog Narrow 5.5mm	EU MDR	Eu Md Class 1	On Market
Analog Narrow 4mm	EU MDR	Eu Md Class 1	On Market
Analog Narrow 7mm	EU MDR	Eu Md Class 1	On Market
Analog Regular 4mm	EU MDR	Eu Md Class 1	On Market
Analog Regular 5.5mm	EU MDR	Eu Md Class 1	On Market
Analog Regular 7mm	EU MDR	Eu Md Class 1	On Market
Analog Tri-Lobe 3.5mm	EU MDR	Eu Md Class 1	On Market
Analog Tri-Lobe 4.3mm	EU MDR	Eu Md Class 1	On Market
Analog Tri-Lobe 5.0mm	EU MDR	Eu Md Class 1	On Market
Analog Wide 4mm	EU MDR	Eu Md Class 1	On Market
Analog Wide 5.5mm	EU MDR	Eu Md Class 1	On Market
BIO \| Conus Implant Analog 4.5/5.0 Platform	EU MDR	Eu Md Class 1	On Market
BIO \| Conus Implant Driver Handpiece 3.0 Long	EU MDR	Eu Md Class 1	On Market
BIO \| Conus Implant Driver Handpiece 3.0 Short	EU MDR	Eu Md Class 1	On Market
BIO \| Conus Implant Driver Handpiece 3.0 Short	EU MDR	Eu Md Class 1	On Market
BIO \| Conus Implant Driver Handpiece 3.5/4.0 Long	EU MDR	Eu Md Class 1	On Market
BIO \| Conus Implant Driver Handpiece 3.5/4.0 Short	EU MDR	Eu Md Class 1	On Market
BIO \| Conus Implant Driver Handpiece 4.5/5.0 Long	EU MDR	Eu Md Class 1	On Market
BIO \| Conus Implant Driver Handpiece 4.5/5.0 Short	EU MDR	Eu Md Class 1	On Market
BIO \| Conus Implant Driver Ratchet 4.5/5.0 Long	EU MDR	Eu Md Class 1	On Market
BIO \| Conus Implant Driver Ratchet 4.5/5.0 Short	EU MDR	Eu Md Class 1	On Market
BIO \| Conus Implant Driver Ratchet 3.0 Platform Long	EU MDR	Eu Md Class 1	On Market
BIO \| Conus Implant Driver Ratchet 3.5/4.0 Long	EU MDR	Eu Md Class 1	On Market
BIO \| Cut Shank Sleeve For DRILL3630L	EU MDR	Eu Md Class 1	On Market
BIO \| Cut Shank Sleeve For DRILL3630S	EU MDR	Eu Md Class 1	On Market
BIO \| Cut Shank Sleeve For DRILL4438L	EU MDR	Eu Md Class 1	On Market
BIO \| Cut Shank Sleeve For DRILL4438S	EU MDR	Eu Md Class 1	On Market
BIO \| Cut Shank Sleeve For DRILLD32L	EU MDR	Eu Md Class 1	On Market
BIO \| Cut Shank Sleeve For DRILLD32S	EU MDR	Eu Md Class 1	On Market
BIO \| Cut Shank Sleeve For DRILLD36L	EU MDR	Eu Md Class 1	On Market
BIO \| Cut Shank Sleeve For DRILLD36S	EU MDR	Eu Md Class 1	On Market
BIO \| Cut Shank Sleeve For DRILLD42L	EU MDR	Eu Md Class 1	On Market
BIO \| Cut Shank Sleeve For DRILLD42S	EU MDR	Eu Md Class 1	On Market
BIO \| Cut Shank Sleeve For DRILLD46L	EU MDR	Eu Md Class 1	On Market
BIO \| Cut Shank Sleeve For DRILLD46S	EU MDR	Eu Md Class 1	On Market
BIO \| Cut Shank Sleeve For DRILLN35L	EU MDR	Eu Md Class 1	On Market
BIO \| Cut Shank Sleeve For DRILLN35S	EU MDR	Eu Md Class 1	On Market
BIO \| Cut Shank Sleeve For DRILLN43L	EU MDR	Eu Md Class 1	On Market
BIO \| Cut Shank Sleeve For DRILLN43S	EU MDR	Eu Md Class 1	On Market
BIO \| Cut Shank Sleeve For DRILLN50L	EU MDR	Eu Md Class 1	On Market
BIO \| Cut Shank Sleeve For DRILLN50S	EU MDR	Eu Md Class 1	On Market

View all 319 devices →