Identity
- Trade Name
- EMSRUN FDA UDI
- Generic Name
- First aid limb splint, mouldable, single-use FDA UDI
- Device Name
- CR-06 EUDAMED
- Model / Reference
- CR-06 EUDAMEDPZJB0001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974567741352 EUDAMEDFDA UDI
- Basic UDI-DI
- 697456774CR-06KV EUDAMED
- FDA Product Code
- HSP FDA UDI
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
- GMDN Term
- First aid limb splint, mouldable, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.5890 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Hand/finger splint, reusable
CR-06 is a Class I medical device used for sterile sampling in patients undergoing surgery or other invasive procedures. It features advanced sterility testing capabilities and is designed to provide accurate and reliable results in high-pressure environments. Our device ensures the highest level of sterility and safety, making it an essential tool for healthcare professionals.
Similar devices
Also classified as Hand/finger splint, reusable.
- Elastic Bandage — Anji Xinyuan Medical Supplies Co.,Ltd. · Class I
- Plastalume — BROWNMED, INC. · Class I
- Splint — Anping Guardian Medical Equipment Co., Ltd · Class I
- ORTHOSIS FRACTURE WRIST-HAND PLASTICAST — AliMed, LLC · Class I
- MedTextile — Medtex Swiss Ltd · Class I
- PERFORMANCE HEALTH — Asp Global, LLC · Class I
- McKie Thumb Splint Pediatric — McKie Splints, LLC · Class I
- Plastalume — BROWNMED, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697456774CR-06KV | 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 75a18dec-33c8-4da5-9d33-8ab4ad58e855 61 fields · synced Aug 2, 2026
- FDA UDI 59e46ff8-5b1e-47da-b512-098d8007bf85 32 fields · synced May 30, 2026