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Elastoosas
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref EIE2316Model intra-extra oral latex elastics
by Micerium Spa
Identity
- Trade Name
- ELASTOOSAS FDA UDI
- Generic Name
- Orthodontic retainer FDA UDI
- Device Name
- Italia intra-extra oral latex elastics / intra-extra oral latex elastics EUDAMEDELASTOOSAS Italia Intraoral Latex Elastics 5000 pcs 3/16" - 2 oz. FDA UDI
- Model / Reference
- EIE2316 EUDAMEDFDA UDIintra-extra oral latex elastics EUDAMED
- Description
- ELASTOOSAS Italia Intraoral Latex Elastics 5000 pcs 3/16" - 2 oz. FDA UDI
Identifiers
- Catalog Number
- EIE2316 FDA UDI
- Primary DI / UDI-DI
- EMICEIE23161 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EMICFAM83H EUDAMED
- FDA Product Code
- KMY FDA UDI
- EMDN Code
- Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS 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
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
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
Elastoosas by Micerium Spa — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic retainer.
- Elastics — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
- Elastics — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
- ELASTICO CORRENTE LONGO PINK CRISTAL RL 4, 5M — ID-LOGICAL INDUSTRIA E COMERCIO LTDA · Class IIa
- MASTER POUCH 15 2G 3/16 LT COUGAR — Ormco Corporation · Class IIa
- Pre-Finisher — TP ORTHODONTICS, INC. · Class I
- Orthodontic Wires and Springs — MEM Dental Technology Co., Ltd · Class IIa
- Orthodontic Wires and Springs — MEM Dental Technology Co., Ltd · Class IIa
- Stainless Steel Spring — American Orthodontics · Class IIa
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 c1a0f03f-fab2-48a6-aaaa-98e20d319cbd 34 fields · synced Jun 19, 2026
- EUDAMED 922e8364-25f3-4d8d-9f99-f1e078b786b7 61 fields · synced Jun 19, 2026