Identity
- Trade Name
- Blu-Mousse® EUDAMEDFDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- Cinch, Mousse & Mach Impression Materials EUDAMEDClassic Blu-Mousse® In Split-Cartridge System FDA UDI
- Model / Reference
- S438S EUDAMEDFDA UDI
- Description
- Classic Blu-Mousse® In Split-Cartridge System FDA UDI
Identifiers
- Catalog Number
- S438S FDA UDI
- Primary DI / UDI-DI
- 10810000524171 EUDAMEDFDA UDI
- Basic UDI-DI
- 081000052IMPRESSIONL3 EUDAMED
- Direct Marketing DI
- 00810000524174 EUDAMED
- FDA Product Code
- ELW FDA UDI
- EMDN Code
- Q01020102 DENTAL IMPRESSION VINYLSILOXANS EUDAMED
- GMDN Term
- Silicone dental impression material FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3660 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Silicone dental impression material
Blu-Mousse® by Parkell, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Silicone dental impression material.
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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 | 081000052IMPRESSIONL3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Parkell Inc.
- EUDAMED SRN
- US-MF-000003761
- Authorised Representative
- Directa AB SE-AR-000002492
Sources (2)
- EUDAMED 10a0446e-5bfe-42f8-8f19-6641c616c017 61 fields · synced May 30, 2026
- FDA UDI bb0a30aa-304b-4398-9370-62d0f52af6cd 36 fields · synced May 30, 2026