Identity
- Trade Name
- TAPE EUDAMEDEMSRUN FDA UDI
- Generic Name
- Multi-purpose surgical skin adhesive tape FDA UDI
- Device Name
- TAPE EUDAMED
- Model / Reference
- CR-AT01 EUDAMEDCR-AT03 EUDAMEDPZJD0009-2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974567744612 EUDAMEDFDA UDI
- Basic UDI-DI
- 697456774CR-AT01TG EUDAMED
- FDA Product Code
- KGX FDA UDI
- EMDN Code
- H900299 TAPES, MEDICAL/SURGICAL - OTHER EUDAMED
- GMDN Term
- Multi-purpose surgical skin adhesive tape FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Tape by Wuxi Emsrun Technology Co., Ltd. — 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 | 697456774CR-AT01TG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wuxi Emsrun Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000008968
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 9a690b83-350b-4be3-a2eb-faeabf0f71d2 61 fields · synced Jun 19, 2026
- FDA UDI 6b97bd67-7444-41f0-b5a1-d11c378333c9 32 fields · synced May 30, 2026