Identity
- Trade Name
- BIO | Max Implant Analog NP EUDAMEDBlue Sky Bio, LLC. FDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Device Name
- ANALOG EUDAMEDBIO | Max Implant Analog NP FDA UDI
- Model / Reference
- BIJH EUDAMEDFDA UDI
- Description
- BIO | Max Implant Analog NP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815131028447 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Dental implant suprastructure, temporary, preformed, single-use
BIO | Max Implant Analog NP by Blue Sky Bio Llc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 c461da33-15df-4a62-a271-b46d3426a739 61 fields · synced Jun 20, 2026
- FDA UDI d1ec946f-0331-4fec-85d7-bb771c431301 33 fields · synced May 30, 2026