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Basics sterile examination set
EUDAMEDFDA UDIClass I (EU MDR)
Ref HY1-130014Model Sterile examination kits
by Hygitech
Identity
- Trade Name
- Basics sterile examination set EUDAMEDHYGITECH FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- BASICS Set 3 instruments HYGITECH Reference: HY-130014 The most popular 3 instrument set is back in an even more economical version! Packaged with 400 pieces, it allows you to make substantial savings Ideal for short procedures or control visits. Packaged in a paper/transparent plastic film for quick identification of the contents. Includes: 1 mirror with a mixing spatula 1 tweezer 1 double probe That's a total of 5 instruments! FDA UDI
- Model / Reference
- Sterile examination kits EUDAMEDHY1-130014 EUDAMEDHY-130014 FDA UDI
- Description
- BASICS Set 3 instruments HYGITECH Reference: HY-130014 The most popular 3 instrument set is back in an even more economical version! Packaged with 400 pieces, it allows you to make substantial savings Ideal for short procedures or control visits. Packaged in a paper/transparent plastic film for quick identification of the contents. Includes: 1 mirror with a mixing spatula 1 tweezer 1 double probe That's a total of 5 instruments! FDA UDI
Identifiers
- Catalog Number
- HY-130014 FDA UDI
- Primary DI / UDI-DI
- 03615140004534 EUDAMEDFDA UDI
- Basic UDI-DI
- 361514H2EXAM081QL EUDAMED
- FDA Product Code
- ECP 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
Basics 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 a763de36-829f-4c9d-accc-41c8d87ed1a5 61 fields · synced Jun 19, 2026
- FDA UDI 8c3157bc-f29c-4b2f-8e4b-3cbf87340500 34 fields · synced May 30, 2026