Identity
- Trade Name
- Disposable bite blocks EUDAMEDDisposable Bite Block FDA UDI
- Generic Name
- Suction system bottle/canister sealing set FDA UDI
- Device Name
- Disposable Bite Blocks EUDAMED
- Model / Reference
- MD-BB-CY-02 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970401816156 EUDAMEDFDA UDI
- Basic UDI-DI
- 697040181BitMatZV EUDAMED
- FDA Product Code
- MNK FDA UDI
- EMDN Code
- G030804 GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS EUDAMED
- GMDN Term
- Suction system bottle/canister sealing set FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Austria 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
Yes
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
No
FDA UDI
Disposable bite blocks by Zhejiang Chuangxiang Medical Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 697040181BitMatZV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhejiang Chuangxiang Medical Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000012417
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 83d8da1d-f13b-406b-ba2c-ade9d1409a09 61 fields · synced Jul 19, 2026
- FDA UDI 51984298-bb0c-4e63-9071-a4b18c305622 32 fields · synced May 29, 2026