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Sterile Dental Chairs Cover
EUDAMEDFDA UDIClass I (EU MDR)
Ref HY1-60040Model Sterile Surgical Drapes
by Hygitech
Identity
- Trade Name
- Sterile Dental Chairs Cover EUDAMEDHYGITECH FDA UDI
- Generic Name
- Surgical dressing/drape kit, single-use FDA UDI
- Device Name
- Dental chair covers provide an effective barrier against bacteria, protecting the patient from cross-infection. HYGITECH supplies both sterile and non-sterile chair covers. Benefits: For the surgeon: Cost effective: These covers reduce the need to use disinfectants and protect the dental chair from bacteria, increasing the lifespan of the chair. Convenient: A single, universal, easy-to-use cover for all 3 parts of the dental chair (6 fixing straps) For the patient: Comfortable and waterproof: it creates a pleasant looking and hygienic environment, giving the patient a feeling of safety and cleanliness. FDA UDI
- Model / Reference
- Sterile Surgical Drapes EUDAMEDHY1-60040 EUDAMEDHY-60040 FDA UDI
- Description
- Dental chair covers provide an effective barrier against bacteria, protecting the patient from cross-infection. HYGITECH supplies both sterile and non-sterile chair covers. Benefits: For the surgeon: Cost effective: These covers reduce the need to use disinfectants and protect the dental chair from bacteria, increasing the lifespan of the chair. Convenient: A single, universal, easy-to-use cover for all 3 parts of the dental chair (6 fixing straps) For the patient: Comfortable and waterproof: it creates a pleasant looking and hygienic environment, giving the patient a feeling of safety and cleanliness. FDA UDI
Identifiers
- Catalog Number
- HY-60040 FDA UDI
- Primary DI / UDI-DI
- 03615140003667 EUDAMEDFDA UDI
- Basic UDI-DI
- 361514H2PREN122V9 EUDAMED
- FDA Product Code
- FXP FDA UDI
- EMDN Code
- T020102 SPECIALISTIC SURGERY DRAPES EUDAMED
- GMDN Term
- Surgical dressing/drape kit, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4040 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 Dental Chairs Cover 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 | 361514H2PREN122V9 | 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 5abcd044-0e97-4dbe-a6a0-0482fbd1fa93 61 fields · synced Jul 12, 2026
- FDA UDI 87314a6e-a7a0-4b78-9594-174625f81d97 34 fields · synced May 30, 2026