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Analog Level Internal Hex 4.5mm Platform
EUDAMEDFDA UDIClass I (EU MDR)
Ref BIH45
Identity
- Trade Name
- Analog Level Internal Hex 4.5mm Platform EUDAMEDBlue Sky Bio, LLC. FDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Device Name
- ANALOG EUDAMEDAnalog Level Internal Hex 4.5mm Platform FDA UDI
- Model / Reference
- BIH45 EUDAMEDFDA UDI
- Description
- Analog Level Internal Hex 4.5mm Platform FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815131028430 EUDAMEDFDA UDI
- Basic UDI-DI
- 081513102ANALOGSUC19N EUDAMED
- FDA Product Code
- EBL FDA UDI
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
- GMDN Term
- Dental implant analog FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3740 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Analog Level Internal Hex 4.5mm Platform by Blue Sky Bio Llc — Class I — 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 | 081513102ANALOGSUC19N | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Blue Sky Bio, LLC
- EUDAMED SRN
- US-MF-000014016
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED e391886c-ec63-41fd-8ecd-32b4c32e2e92 61 fields · synced Jun 18, 2026
- FDA UDI bee10ebb-9737-4380-b565-9953f83d5ac4 33 fields · synced May 30, 2026