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Sterile examination set
EUDAMEDFDA UDIClass I (EU MDR)
Ref HY1-130025Model Sterile examination kits
by Hygitech
Identity
- Trade Name
- Sterile examination set EUDAMEDHYGITECH FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Comprehensive examination kit: a ready-to-use tray for all kinds of procedures Contents: 1 mouth mirror, 1 probe, 1 pair of tweezers, 1 ear-loop mask, 1 tissue, 2 cotton rolls, 1 spatula, 1 saliva pump. FDA UDI
- Model / Reference
- Sterile examination kits EUDAMEDHY1-130025 EUDAMEDHY-130025 FDA UDI
- Description
- Comprehensive examination kit: a ready-to-use tray for all kinds of procedures Contents: 1 mouth mirror, 1 probe, 1 pair of tweezers, 1 ear-loop mask, 1 tissue, 2 cotton rolls, 1 spatula, 1 saliva pump. FDA UDI
Identifiers
- Catalog Number
- HY-130025 FDA UDI
- Primary DI / UDI-DI
- 03615140002592 EUDAMEDFDA UDI
- Basic UDI-DI
- 361514H2EXAM081QL EUDAMED
- FDA Product Code
- EIY FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sterile examination set by Hygitech — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 361514H2EXAM081QL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hygitech
- EUDAMED SRN
- FR-MF-000007549
Sources (2)
- EUDAMED 99aed5fc-510e-4731-9e4a-aff5398972f8 61 fields · synced Jul 22, 2026
- FDA UDI 6b9502c0-5ea4-44f3-9303-630cbb34c153 34 fields · synced May 30, 2026