Identity
- Trade Name
- Huanhai EUDAMEDBreathing bags FDA UDI
- Generic Name
- Breathing circuit bag, single-use FDA UDI
- Model / Reference
- HH-HHN-A-1L EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972249260016 EUDAMEDFDA UDI
- Basic UDI-DI
- 697224926HHNAML EUDAMED
- FDA Product Code
- BTC FDA UDI
- EMDN Code
- R03020101 ANAESTHESIA BALLOONS EUDAMED
- GMDN Term
- Breathing circuit bag, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5320 FDA UDI
- Market of Registration
- Türkiye 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
Ethylene Oxide FDA UDI
Huanhai by Shandong Jinlai Huanhai Medical Technology Co., Ltd — Class IIa — 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 | 697224926HHNAML | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shandong Jinlai Huanhai Medical Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000020598
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 6a14e461-6fa2-4320-a98e-5bec6679f97d 61 fields · synced Oct 6, 2026
- FDA UDI 6885ec1b-b165-42a4-9aef-e7f675ee87ad 32 fields · synced May 30, 2026