- Organization name
- UDI-DI code
- Reference / catalog number
US-MF-000014016Impression Coping Internal Hex Level 3.5mm Platform is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Blue Sky Bio, LLC. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jul 31, 2026
081006022COPINGSUC1EEPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00810060222164
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Germany; available across 7 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Dec 21, 2009 | Still on market |
| Austria | — | Still on market |
| EL | — | Still on market |
| France | — | Still on market |
| Ireland | — | Still on market |
| Italy | — | Still on market |
| Portugal | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
00810060222164Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
081006022COPINGSUC1EEhttps://blueskybio.com/pages/instructions-for-use_0UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q010207DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRYNo certificate specifically references this device's Basic UDI-DI.
081006022DRIVERRUC1L5On the marketHandle Multi Unit Abutment081006022DRIVERRUC1L5On the marketImplant Analog BIO | Quattro Narrow081513102ANALOGSUC19NOn the marketImpression Coping Internal Hex Level 4.5mm Platform081006022COPINGSUC1EEOn the marketImpression Coping Narrow 4mm081006022COPINGSUC1EEOn the marketImpression Coping Narrow 5.5mm081006022COPINGSUC1EEOn the marketNo certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.