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Amcop Bioactivator
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref BIO-F1MModel Micerium AMCOP BioactivatorsRef BC3-DEEPRef BIO-0S2MRef BIO-SC6MRef BTC3-DTM
by Micerium Spa
Identity
- Trade Name
- Amcop Bioactivator FDA UDI
- Generic Name
- Orthodontic retainer FDA UDI
- Device Name
- Micerium AMCOP Bioactivators / Micerium AMCOP Bioactivators EUDAMEDAmcop Bioactivator AMCOP BIOACTIVATOR Class I Mod. S Basic Size 5 - 65 mm FDA UDIAmcop Bioactivator AMCOP BIOACTIVATOR Class II Mod. SC Size 5 - 65 mm FDA UDIAmcop Bioactivator AMCOP BIOACTIVATOR Class I Mod.0S Integral Size 2 - 50 mm FDA UDIAmcop Bioactivator BIOACTIVATOR 1 pc. Class I Mod. C DEEP Size 3 - 55 mm FDA UDIAmcop Bioactivator AMCOP BIOACTIVATOR Class III Mod. TC DTM Size 3 - 55 mm FDA UDIAmcop Bioactivator AMCOP BIOACTIVATOR Class I Mod. F Integral Size 1 - 45 mm FDA UDI
- Model / Reference
- BIO-SC6M EUDAMEDFDA UDIBIO-0S2M EUDAMEDFDA UDIBC3-DEEP EUDAMEDFDA UDIBTC3-DTM EUDAMEDFDA UDIBIO-F1M EUDAMEDFDA UDIMicerium AMCOP Bioactivators EUDAMEDBIO-BS5M FDA UDI
- Description
- Amcop Bioactivator AMCOP BIOACTIVATOR Class I Mod. S Basic Size 5 - 65 mm FDA UDIAmcop Bioactivator AMCOP BIOACTIVATOR Class II Mod. SC Size 5 - 65 mm FDA UDIAmcop Bioactivator AMCOP BIOACTIVATOR Class I Mod.0S Integral Size 2 - 50 mm FDA UDIAmcop Bioactivator BIOACTIVATOR 1 pc. Class I Mod. C DEEP Size 3 - 55 mm FDA UDIAmcop Bioactivator AMCOP BIOACTIVATOR Class III Mod. TC DTM Size 3 - 55 mm FDA UDIAmcop Bioactivator AMCOP BIOACTIVATOR Class I Mod. F Integral Size 1 - 45 mm FDA UDI
Identifiers
- Catalog Number
- BIO-BS5M FDA UDIBIO-SC6M FDA UDIBIO-0S2M FDA UDIBC3-DEEP FDA UDIBTC3-DTM FDA UDIBIO-F1M FDA UDI
- Primary DI / UDI-DI
- EMICBIOSC6M1 EUDAMEDFDA UDIEMICBIO0S2M1 EUDAMEDFDA UDIEMICBC3DEEP1 EUDAMEDFDA UDIEMICBTC3DTM1 EUDAMEDFDA UDIEMICBIOF1M1 EUDAMEDFDA UDIEMICBIOBS5M1 FDA UDI
- Basic UDI-DI
- ++EMICFAM8BVW EUDAMED
- FDA Product Code
- KMY FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic retainer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.5525 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
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
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
Category: Orthodontic retainer
Amcop Bioactivator by Micerium Spa — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Orthodontic retainer.
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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 (11)
- FDA UDI 2935bf11-dece-4f8f-a1f4-4fb7a21de368 34 fields · synced Sep 17, 2026
- FDA UDI 30e578b7-410a-465a-aa7a-c76dc283f57d 34 fields · synced May 29, 2026
- FDA UDI bd8b4129-59f7-4730-af13-4c6277d2295f 34 fields · synced May 30, 2026
- FDA UDI 0183f3c1-fe11-4201-842a-07696da9672e 34 fields · synced May 30, 2026
- FDA UDI 390d9271-543a-45f0-bf2b-fd0205763a35 34 fields · synced May 30, 2026
- FDA UDI c449c6db-83b9-400c-89de-849b1c36846e 34 fields · synced May 30, 2026
- EUDAMED 8f867eef-3a5c-47a0-bd93-1c8199e30bdc 61 fields · synced Jul 8, 2026
- EUDAMED 267b2326-1985-45ea-822f-489ed1fc03ad 61 fields · synced Jul 8, 2026
- EUDAMED fad0b9ba-7ef0-4da2-a9e9-b733400ddf3d 61 fields · synced Jul 8, 2026
- EUDAMED 822e978a-aee4-408d-a988-d97ecb206a32 61 fields · synced Jul 8, 2026
- EUDAMED a5f71beb-9a3a-4023-889f-c5a743c09eb8 61 fields · synced Aug 1, 2026