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Ena Post
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref CS050-2RModel Diamond Strips
by Micerium Spa
Identity
- Trade Name
- Ena Post FDA UDI
- Generic Name
- Dental abrasive strip, reusable FDA UDI
- Device Name
- Shiny Strips / Diamond Strips EUDAMEDEnamel Plus Shiny Ricambi Diamond Strips FDA UDI
- Model / Reference
- CS050-2R EUDAMEDFDA UDIDiamond Strips EUDAMED
- Description
- Enamel Plus Shiny Ricambi Diamond Strips FDA UDI
Identifiers
- Catalog Number
- CS050-2R FDA UDI
- Primary DI / UDI-DI
- EMICCS0502R1 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EMICFAM1D7UE EUDAMED
- FDA Product Code
- EHM FDA UDI
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
- GMDN Term
- Dental abrasive strip, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6010 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
Yes
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
No
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 120 Millimeter FDA UDIHeight — 2.0 Millimeter FDA UDI
Category: Dental abrasive strip, reusable
Ena Post by Micerium Spa — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental abrasive strip, reusable.
- Two Striper — ABRASIVE TECHNOLOGY, LLC · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Defend — Young Innovations, Inc. · Class I
- KOMET Diamond Strip, Polishing Strip — Gebr. Brasseler GmbH & Co. KG · Class I
- Two Striper — ABRASIVE TECHNOLOGY, LLC · Class I
- SB-60HR — GNI Co., Ltd · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- SB-15HD — GNI Co., Ltd · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Micerium Spa
Sources (2)
- FDA UDI 68798434-47ce-44d2-94e9-eb198bbfc826 35 fields · synced Jul 31, 2026
- EUDAMED 3224fae0-7a58-46c5-8db4-49df80c86c04 61 fields · synced Jul 31, 2026