Identity
- Trade Name
- Batrik Bitestrong’/19mm/Reuseable FDA UDI
- Generic Name
- Endoscopic bite block, basic, single-use FDA UDI
- Device Name
- Bite Blocks EUDAMEDBitestrongTM Bite Blocks, 19 mm, Reusable, Adult, without strap FDA UDI
- Model / Reference
- B6T-N EUDAMEDFDA UDI
- Description
- BitestrongTM Bite Blocks, 19 mm, Reusable, Adult, without strap FDA UDI
Identifiers
- Catalog Number
- B6T-N FDA UDI
- Primary DI / UDI-DI
- 00690521023062 EUDAMED00690521000339 FDA UDI
- Basic UDI-DI
- 6905210BITEB1000RK EUDAMED
- FDA Product Code
- MNK FDA UDI
- EMDN Code
- G030804 GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS EUDAMED
- GMDN Term
- Endoscopic bite block, basic, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Bite Blocks by Batrik Medical Manufacturing Inc. — 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 | 6905210BITEB1000RK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Batrik Medical Manufacturing Inc.
- EUDAMED SRN
- CA-MF-000007738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED e375e886-f65f-402d-9ae7-bd7ed65289a1 61 fields · synced Jun 10, 2026
- FDA UDI a9600ae6-6f72-491e-9824-b7f4a9fc1bbc 36 fields · synced May 22, 2026