← Back to catalogue
Transparent Drawstring sack
EUDAMEDFDA UDIClass I (EU MDR)
Ref HY1-63117Model Sterile Surgical Drapes
by Hygitech
Identity
- Trade Name
- Transparent Drawstring sack EUDAMEDHYGITECH FDA UDI
- Generic Name
- Medical bag FDA UDI
- Device Name
- The HYGITECH transparent bag with sliding bootlace allows to protect the control unit without compromising the sterility during the surgery. Characteristics: -Sterile (EO), single use -25 in a pack -Transparent -Size 60 x 70 cm FDA UDI
- Model / Reference
- Sterile Surgical Drapes EUDAMEDHY1-63117 EUDAMEDHY-63117 FDA UDI
- Description
- The HYGITECH transparent bag with sliding bootlace allows to protect the control unit without compromising the sterility during the surgery. Characteristics: -Sterile (EO), single use -25 in a pack -Transparent -Size 60 x 70 cm FDA UDI
Identifiers
- Catalog Number
- HY-63117 FDA UDI
- Primary DI / UDI-DI
- 03615140003063 EUDAMEDFDA UDI
- Basic UDI-DI
- 361514H2PREN122V9 EUDAMED
- FDA Product Code
- GFJ FDA UDI
- EMDN Code
- T020102 SPECIALISTIC SURGERY DRAPES EUDAMED
- GMDN Term
- Medical bag 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
No
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
Transparent Drawstring sack 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hygitech
- EUDAMED SRN
- FR-MF-000007549
Sources (2)
- EUDAMED 1e25ce6d-20e0-41c9-89b7-bbca64584184 61 fields · synced Jun 19, 2026
- FDA UDI 58903f01-b7e2-4d88-8d1c-a81bae5673ed 34 fields · synced May 30, 2026