Medical Cool The Pain
EUDAMEDFDA UDIClass I (EU MDR)
by Jiangsu Aspidistra elatior Blume bio-medical Technology Co., Ltd
Identity
- Trade Name
- Aspidistra FDA UDI
- Generic Name
- Cold/cool therapy gel FDA UDI
- Device Name
- MEDICAL COOL THE PAIN EUDAMED
- Model / Reference
- BI-Ⅲ EUDAMEDBI-III FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973709448883 EUDAMEDFDA UDI
- Basic UDI-DI
- 697370944MCPDUR5 EUDAMED
- FDA Product Code
- IMD FDA UDI
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
- GMDN Term
- Cold/cool therapy gel FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5710 FDA UDI
- Market of Registration
- Austria 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
No
Manufacturing Date
Yes
Category: Hot/cold therapy pack, reusable
Medical Cool The Pain by Jiangsu Aspidistra elatior Blume bio-medical Technology Co. , Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697370944MCPDUR5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- EUDAMED SRN
- CN-MF-000035402
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 155b0b29-fea3-41d5-8fd1-712339b86a58 61 fields · synced Jul 15, 2026
- FDA UDI 0f105751-5486-4bfe-afe4-7222d8d319ee 32 fields · synced May 30, 2026