Identity
- Trade Name
- RHINO RESCUE EUDAMEDFDA UDI
- Generic Name
- Woven gauze roll/sheet FDA UDI
- Device Name
- Compressed gauze EUDAMEDCompressed gauze/Z-fold FDA UDI
- Model / Reference
- PZSB0034 EUDAMEDPZSB0034/Z-fold FDA UDI
- Description
- Compressed gauze/Z-fold FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975675780011 EUDAMEDFDA UDI
- Basic UDI-DI
- 697567578CG01QN EUDAMED
- FDA Product Code
- NAB FDA UDI
- EMDN Code
- M0201010101 COTTON GAUZE, CUT, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
- GMDN Term
- Woven gauze roll/sheet FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4014 FDA UDI
- Market of Registration
- Austria 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
Rhino Rescue by Emsrun Group — 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 | 697567578CG01QN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Emsrun Group
- EUDAMED SRN
- CN-MF-000037456
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED bf385c6c-8307-45bc-8bf1-51fda5c8d4c0 61 fields · synced Jun 8, 2026
- FDA UDI 5d4f3b7d-73cd-46e5-84e8-783b35569bf7 33 fields · synced May 30, 2026