← Back to catalogue
Sterile examination set
EUDAMEDFDA UDIClass I (EU MDR)
Ref HY1-130012Model Sterile examination kits
by Hygitech
Identity
- Trade Name
- Sterile examination set EUDAMEDHYGITECH FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Ideal for short procedures or simple patient visits. Packed in a transparent plastic peel pack tray, which provides easy identification of contents. Contents: 1 mouth mirror, 1 probe, 1 pair of tweezers. FDA UDI
- Model / Reference
- Sterile examination kits EUDAMEDHY1-130012 EUDAMEDHY-130012 FDA UDI
- Description
- Ideal for short procedures or simple patient visits. Packed in a transparent plastic peel pack tray, which provides easy identification of contents. Contents: 1 mouth mirror, 1 probe, 1 pair of tweezers. FDA UDI
Identifiers
- Catalog Number
- HY-130012 FDA UDI
- Primary DI / UDI-DI
- 03615140002561 EUDAMEDFDA UDI
- Basic UDI-DI
- 361514H2EXAM081QL EUDAMED
- FDA Product Code
- KDD 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
- 878.4800 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hygitech
- EUDAMED SRN
- FR-MF-000007549
Sources (2)
- EUDAMED 959deeeb-d394-4980-b016-5e1f87921a4e 61 fields · synced Jul 8, 2026
- FDA UDI 6defeaf5-367b-4441-aac6-6b12e0d4d825 34 fields · synced May 29, 2026